G-BEAM STAINLESS STEEL FUSION BEAM L120MM D5.4MM STERILE
Report
- Report Number
- 9680825-2021-00036
- Event Type
- Injury
- Date Received
- April 30, 2021
- Date of Event
- April 7, 2021
- Report Date
- August 11, 2021
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HWC
- UDI-DI
- 18053504360605
- PMA / PMN Number
- K172698
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875120 BATCH R1226807 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00036) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875135 BATCH B1235613 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00037) TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) THE AFFECTED DEVICES, RECEIVED ON JUNE 10, 2021, WAS EXAMINED BY ORTHOFIX QUALITY OPERATION DEPARTMENT. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED. THE DEVICES ARE BROKEN IN CORRESPONDENCE TO THE THREADED PART WHICH IS NOW MISSING AS LEFT ON PATIENT BONE. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT SHOW ANY ANOMALIES. THE DEVICES WERE THEN SENT TO AN EXTERNAL LABORATORY FOR THE CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE RESULTS OF THE TECHNICAL INVESTIGATION CONFIRMED THE RAW MATERIAL CONFORMITY TO ORTHOFIX SPECIFICATIONS. BOTH DEVICES BROKE DUE TO FATIGUE FAILURE. MEDICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION, WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. (B)(6) 2021: "IN THIS CASE THREE G-BEAMS WERE INSERTED INTO THE RIGHT FOOT OF A 60 YEAR OLD PATIENT WITH DIABETES AND CHARCOT FOOT, ON (B)(6), 18 WEEKS AGO. THERE WERE 1 X 7.4 MM AND 2 X 5.4 M BEAMS. ROUTINE X-RAY ON (B)(6), AT 16 WEEKS, REVEALED BREAKAGE OF BOTH OF THE 5.4 MM BEAMS. THE SURGEON PLANS FURTHER SURGERY. WE KNOW THAT IN CHARCOT FOOT THE PATIENT CANNOT FEEL HOW MUCH LOAD THEY ARE PUTTING ON THE FOOT AND IT MAY BE VERY DIFFICULT FOR THEM TO PARTIALLY WEIGHTBEAR. THE X-RAYS SHOW A REASONABLY NORMAL LEFT FOOT, AND A RIGHT FOOT THAT IS SWOLLEN WITH COMPLETE LOSS OF THE LONGITUDINAL ARCH WITH WEIGHT BEING CARRIED BY THE MIDFOOT. A 7.4 MM BEAM HAS BEEN INSERTED INTO THE 1ST METATARSAL, NAVICULAR AND TALUS. ONE 5.4 MM BEAM HAS BEEN INSERTED INTO THE 3RD METATARSAL THROUGH A CUBOID BONE INTO THE TALUS AND THE SECOND UP THE 4TH METATARSAL INTO THE CALCANEUS. BOTH 5.4 BEAMS HAVE BROKEN AT THE ENTRY INTO THE HIND FOOT. IT SEEMS THAT BREAKAGE OF THESE BEAMS IS VERY UNUSUAL, AND IN THIS CASE BOTH THE SMALLER BEAMS WILL HAVE BROKEN BECAUSE OF A HIGH LOAD OVER A LONG PERIOD. THE LATERAL ARCH IS NOW NOT BEING SUPPORTED SO FURTHER SURGERY IS PLANNED. THE PATIENT IS QUITE HEAVY. IT DOES SEEM THAT THERE WAS A VERY GOOD RECOVERY PROTOCOL WITH LIMITED WEIGHTBEARING. HOWEVER, THE PATIENT IS 114 KG WHICH IS QUITE HEAVY. SOMETHING MUST HAVE LOADED THE SMALLER G BEAMS TO CAUSE THE BREAKAGE. IN SPITE OF GOOD COMPLIANCE BY THE PATIENT, JUST STANDING ON THE LIMB WILL PRODUCE A LARGE LOAD. IT WILL BE INTERESTING TO FOLLOW THIS PATIENT AFTER THE NEXT OPERATION". JUNE 2, 2021 WITH THE FURTHER INFO PROVIDED: "THIS PATIENT NOW HAS 6 BEAMS IN THEIR FOOT. THIS IS AN IMPRESSIVE SALVAGE PROCEDURE. THERE SHOULD BE ENOUGH SUPPORT HERE TO AVOID THE RISK OF BREAKAGE. AS LONG AS THE SOFT TISSUES HEAL THE PATIENT SHOULD DO WELL. THIS IS A VERY IMPRESSIVE RECONSTRUCTION. IF THE WOUNDS HAVE HEALED WELL THE RESULT SHOULD BE GOOD". (B)(6) 2021 WITH THE OUTCOME OF THE TECHNICAL EVALUATION: "THE TECHNICAL REPORT SHOWS CLEARLY THAT THESE BEAMS FAILED BECAUSE OF CYCLIC LOADING LEADING TO FATIGUE FAILURE. THE REPORT HIGHLIGHTS THE HIGH LOADING THAT CAN BE ANTICIPATED IN SUCH A HEAVY PATIENT WITH CHARCOT DISEASE". CONCLUSION THE RESULTS OF THE TECHNICAL INVESTIGATION EVIDENCED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS. BOTH DEVICES BROKE DUE TO FATIGUE FAILURE. BASED ON THE RESULTS OF THE TECHNICAL EVALUATION PERFORMED ON THE RETURNED DEVICES, AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS NOT DEVICE RELATED. ORTHOFIX SRL HISTORICAL RECORDS SHOW THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875120 BATCH R1226807 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 140 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00036). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875135 BATCH B1235613 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 79 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00037). TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037): THE TECHNICAL EVALUATION ON THE RETURNED DEVICES, RECEIVED ON JUNE 10, 2021, IS CURRENTLY ON GOING. MEDICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037): THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-875120 AND 99-875135 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY) BATCH NUMBERS: R1226807 AND B1235613 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY) QUANTITY: 1 EACH. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FOOT SURGERY DESCRIPTION: CORRECTION PATIENT INFORMATION: 60 YEARS, MALE, WITH DIABETES AND CHARCOT FOOT. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "(B)(6) 2020, MALE PATIENT, AGE 60 WITH A COLLAPSED FOOT VALVE DUE TO DIABETES. PRETTY GOOD SOFT TISSUES, BUT THE CUBOID BONE HAD STARTED MIGRATING IN PLANTAR DIRECTION. INITIAL PLAN WAS MTP1 FUSION W/ VARIAX PLATE AND 5.4MM G-BEAMS IN 3RD OR 4TH, AND 7.4MM BEAM IN THE SUBTALAR JOINT. AFTER SOME DISCUSSION, THE PLATE WAS SKIPPED AND SURGEON WENT FOR G-BEAMS ALL THE WAY. STATUS OF THE SUBTALAR JOINT WAS PRETTY GOOD, AND NO SUBTALAR FUSION WAS PERFORMED. (B)(6) 2021 - DURING X-RAY INVESTIGATION BREAKAGE OF THE 5.4MM G-BEAMS IN 2ND AND 4TH METATARSAL BONE WAS DISCOVERED. AT THIS POINT SURGEON CONSIDER REVISION TREATMENT OPTIONS.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION / UN-RETRIEVED DEVICE FRAGMENTS) AN ADDITIONAL SURGERY WILL BE REQUIRED (NOT YET DEFINED) A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPY OF OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PRODUCT IS NOT AVAILABLE FOR RETURN (STILL ON PATIENT) ON APRIL 21, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: PATIENT HEIGHT 194CM AND WEIGHT 114 KG PATIENT HAS FOLLOWED THE INSTRUCTIONS WITH MINIMAL MOVEMENT IN THE BEGINNING AND MAXIMUM 500M/DAY THE LAST MONTH BEFORE THE FAILURE. THE PATIENT HAS BEEN FULLY COMPLIANT TO REHAB. FOOT PROTECTED WITH PLASTER OF PARIS, MAXIMUM LOAD 10 KG THE FIRST 10 WEEKS. UNTIL NOW, THE PATIENT IS USING A WALKER. ON (B)(6) 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: YESTERDAY, WE PERFORMED THE REVISION SURGERY. THE EXISTING G-BEAM IMPLANTS WERE REMOVED. THE BROKEN TIPS FROM THE 5.4MM BEAMS COULDN'T BE REMOVED AND WERE LEFT INSIDE THE PATIENT. JOINT SURFACES PREPARED FOR NEW FUSIONS BETWEEN TALUS/CALCANEOUS AND TARSAL BONES + SUBTALAR JOINT. NEW BEAMS: 7.4MM BEAM IN 1ST METATARSAL, 5.4MM BEAMS IN 2ND-4TH METATARSAL, 2X 7.4MM BEAMS IN SUBTALAR JOINT. PATIENT STATUS GOOD, EXCELLENT WOUND HEALING FROM FIRST SURGERY, ACHILLES TENDON SOMEWHAT SHORT BUT WAS LENGTHENED DURING REVISION SURGERY. THE ATTACHED X-RAYS ARE JUST QUICK INTRA-OP SHOTS, TO GIVE YOU AN IDEA WHAT HAPPENED YESTERDAY. HIGH QUALITY POST-OP X-RAYS WILL BE SENT LATER (NOT YET RECEIVED BY ORTHOFIX SRL). ON JULY 30, 2021, ORTHOFIX SRL RECEIVED SOME X-RAY IMAGES RELATED TO THE REVISION SURGERY PERFORMED ON (B)(6) 2021. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER : (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2021-00037.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-875120 AND 99-875135 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY). BATCH NUMBERS: R1226807 AND B1235613 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY). QUANTITY: 1 EACH. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: 60 YEARS, MALE, WITH DIABETES AND CHARCOT FOOT. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "(B)(6) 2020: MALE PATIENT, AGE 60 WITH A COLLAPSED FOOT VALVE DUE TO DIABETES. PRETTY GOOD SOFT TISSUES, BUT THE CUBOID BONE HAD STARTED MIGRATING IN PLANTAR DIRECTION. INITIAL PLAN WAS MTP1 FUSION W/ VARIAX PLATE AND 5.4MM G-BEAMS IN 3RD OR 4TH, AND 7.4MM BEAM IN THE SUBTALAR JOINT. AFTER SOME DISCUSSION, THE PLATE WAS SKIPPED AND SURGEON WENT FOR G-BEAMS ALL THE WAY. STATUS OF THE SUBTALAR JOINT WAS PRETTY GOOD, AND NO SUBTALAR FUSION WAS PERFORMED. (B)(6) 2021: DURING X-RAY INVESTIGATION BREAKAGE OF THE 5.4MM G-BEAMS IN 2ND AND 4TH METATARSAL BONE WAS DISCOVERED. AT THIS POINT SURGEON CONSIDER REVISION TREATMENT OPTIONS.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION/UN-RETRIEVED DEVICE FRAGMENTS). AN ADDITIONAL SURGERY WILL BE REQUIRED (NOT YET DEFINED). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PRODUCT IS NOT AVAILABLE FOR RETURN (STILL ON PATIENT). ON APRIL 21 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: PATIENT HEIGHT 194CM AND WEIGHT 114 KG. PATIENT HAS FOLLOWED THE INSTRUCTIONS WITH MINIMAL MOVEMENT IN THE BEGINNING AND MAXIMUM 500M/DAY THE LAST MONTH BEFORE THE FAILURE. THE PATIENT HAS BEEN FULLY COMPLIANT TO REHAB. FOOT PROTECTED WITH PLASTER OF PARIS, MAXIMUM LOAD 10 KG THE FIRST 10 WEEKS. UNTIL NOW, THE PATIENT IS USING A WALKER. ON JUNE 1, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: YESTERDAY, WE PERFORMED THE REVISION SURGERY. THE EXISTING G-BEAM IMPLANTS WERE REMOVED. THE BROKEN TIPS FROM THE 5.4MM BEAMS COULDN'T BE REMOVED AND WERE LEFT INSIDE THE PATIENT. JOINT SURFACES PREPARED FOR NEW FUSIONS BETWEEN TALUS/CALCANEOUS AND TARSAL BONES + SUBTALAR JOINT. NEW BEAMS: 7.4MM BEAM IN 1ST METATARSAL, 5.4MM BEAMS IN 2ND-4TH METATARSAL, 2X 7.4MM BEAMS IN SUBTALAR JOINT. PATIENT STATUS GOOD, EXCELLENT WOUND HEALING FROM FIRST SURGERY, ACHILLES TENDON SOMEWHAT SHORT BUT WAS LENGTHENED DURING REVISION SURGERY. THE ATTACHED X-RAYS ARE JUST QUICK INTRA-OP SHOTS, TO GIVE YOU AN IDEA WHAT HAPPENED YESTERDAY. HIGH QUALITY POST-OP X-RAYS WILL BE SENT LATER (NOT YET RECEIVED BY ORTHOFIX SRL). MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2021-00037.
ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875120 BATCH R1226807 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 140 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00036) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-875135 BATCH B1235613 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 79 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. (MFR REPORT 9680825-2021-00037) TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) A TECHNICAL EVALUATION OF THE BROKEN DEVICES USED WAS NOT PERFORMED AS THE DEVICES ARE CURRENTLY IN USE BY PATIENT. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES ARE REMOVED FROM THE PATIENT AND RETURNED TO ORTHOFIX SRL. MEDICAL EVALUATION (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037) THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-875120 AND 99-875135 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY) BATCH NUMBERS: R1226807 AND B1235613 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY) QUANTITY: 1 EACH DATE OF INITIAL SURGERY: (B)(6) 2020 BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FOOT SURGERY DESCRIPTION: CORRECTION PATIENT INFORMATION: (B)(6) , MALE, WITH DIABETES AND CHARCOT FOOT PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: "(B)(6) 2020 - MALE PATIENT, (B)(6) WITH A COLLAPSED FOOT VALVE DUE TO DIABETES. PRETTY GOOD SOFT TISSUES, BUT THE CUBOID BONE HAD STARTED MIGRATING IN PLANTAR DIRECTION. INITIAL PLAN WAS MTP1 FUSION W/ VARIAX PLATE AND 5.4MM G-BEAMS IN 3RD OR 4TH, AND 7.4MM BEAM IN THE SUBTALAR JOINT. AFTER SOME DISCUSSION, THE PLATE WAS SKIPPED AND SURGEON WENT FOR G-BEAMS ALL THE WAY. STATUS OF THE SUBTALAR JOINT WAS PRETTY GOOD, AND NO SUBTALAR FUSION WAS PERFORMED. (B)(6) 2021 - DURING X-RAY INVESTIGATION BREAKAGE OF THE 5.4MM G-BEAMS IN 2ND AND 4TH METATARSAL BONE WAS DISCOVERED. AT THIS POINT SURGEON CONSIDER REVISION TREATMENT OPTIONS.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION / UN-RETRIEVED DEVICE FRAGMENTS) AN ADDITIONAL SURGERY WILL BE REQUIRED (NOT YET DEFINED) A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPY OF OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE AVAILABLE PRODUCT IS NOT AVAILABLE FOR RETURN (STILL ON PATIENT) ON (B)(6) 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE LOCAL DISTRIBUTOR: PATIENT HEIGHT 194CM AND WEIGHT (B)(6) PATIENT HAS FOLLOWED THE INSTRUCTIONS WITH MINIMAL MOVEMENT IN THE BEGINNING AND MAXIMUM 500M/DAY THE LAST MONTH BEFORE THE FAILURE. THE PATIENT HAS BEEN FULLY COMPLIANT TO REHAB. FOOT PROTECTED WITH PLASTER OF PARIS, MAXIMUM LOAD 10 KG THE FIRST 10 WEEKS. UNTIL NOW, THE PATIENT IS USING A WALKER. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER : (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2021-00037.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653486 | G-BEAM STAINLESS STEEL FUSION BEAM L120MM D5.4MM STERILE | G-BEAM STAINLESS STEEL FUSION BEAM L120MM D5.4MM STERILE | HWC | ORTHOFIX SRL | 99-875120 | R1226807 | 18053504360605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |