CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
Report
- Report Number
- 9680825-2017-00062
- Event Type
- Injury
- Date Received
- November 30, 2017
- Date of Event
- October 30, 2017
- Report Date
- January 16, 2018
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- UDI-DI
- 18054242514749
- PMA / PMN Number
- K161466
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T93790 LOT V1431055 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00062) ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193282 LOT 1707942 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00063) ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193283 LOT 1708391 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00064) ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193281 LOT 1708106 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00065) TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON NOVEMBER 13 AND NOVEMBER 17, 2017, WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. ALL DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. 1) CHIMAERA HFS LAG SCREW SLIDING CODE 99-T93790 (PLEASE REFER TO MFR REPORT 9680825-2017-00062): THE VISUAL CHECK EVIDENCED STRONG SIGNS OF DAMAGING. IT WAS NOT POSSIBLE TO PERFORM THE DIMENSIONAL AND FUNCTIONAL CHECK AS THE MOVING GEAR IS NOW STUCK ON THE MAIN BODY. 2) LAG SCREWDRIVER RETENTION ROD CODE 193282 (PLEASE REFER TO MFR REPORT 9680825-2017-00063): THE VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE DEVICE IS STILL CONFORMING TO ORTHOFIX SPECIFICATIONS. 3) LAG SCREWDRIVER CODE 193283 (PLEASE REFER TO MFR REPORT 9680825-2017-00064): THE VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE DEVICE IS STILL CONFORMING TO ORTHOFIX SPECIFICATIONS. 4) LAG SCREW COMPRESSION ROD CODE 193281 (PLEASE REFER TO MFR REPORT 9680825-2017-00065): THE VISUAL CHECK EVIDENCED THAT THE THREADED PART OF THE DEVICE IS BROKEN FOR FLEXIONAL OVERLOAD. THE DIMENSIONAL AND FUNCTIONAL CHECK EVIDENCED THE DEVICE CONFORMITY, APART FROM THE BROKEN PART. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE EVENT TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION, PERFORMED ON THE RETURNED DEVICES, WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. NOVEMBER (B)(6) 2017: "IN THIS INCIDENT A SHORT 125 DEGREE CHIMAERA NAIL WAS BEING INSERTED INTO THE LEFT FEMUR OF A FEMALE OF (B)(6) YEARS. THE SURGEON THEN COMPRESSED THE FRACTURE. AT THE END OF THIS PROCEDURE IT WAS FOUND THAT THE LAG SCREW HAD BEEN REMOVED FROM THE BONE. IT WAS IMPOSSIBLE TO REMOVE THE SCREWDRIVER FROM THE LAG SCREW. THE SURGEON THEN INSERTED ANOTHER LAG SCREW, LENGTH UNSPECIFIED, USING THE LAG SCREW RETENTION ROD. THE LATTER BROKE OFF, LEAVING A PORTION INSIDE THE LAG SCREW, BUT THE OPERATION WAS COMPLETED SATISFACTORILY. WE HAVE 2 X-RAY IMAGES WHICH SEEM TO BE IDENTICAL. BOTH APPEAR TO BE OF THE FINAL RESULT, WITH IMPLANTS IN PLACE AND A PIECE OF THE RETENTION ROD PROTRUDING FROM THE MAIN CEPHALIC SCREW. THE FRACTURE REDUCTION SEEMS TO BE EXCELLENT IN THE AP VIEW (BUT WE DO NOT HAVE A LATERAL). THE MAIN CEPHALIC SCREW IS INSERTED WITH THE TIP-APEX DISTANCE BEING VERY CLOSE TO 20 MM. I HAVE THE FOLLOWING COMMENTS: 1). THE MAIN LAG SCREW IS BEING INSERTED WITH A SUPPLEMENTARY CEPHALIC SCREW. IT WAS INSERTED EXACTLY IN THE CENTRE OF THE FEMORAL NECK (IN THE AP VIEW - WE DO NOT HAVE A LATERAL VIEW). THIS IS INCORRECT IF A SUPPLEMENTARY SCREW IS TO BE USED, BECAUSE THERE MAY NOT BE ROOM FOR THE LATTER TO FIT INSIDE THE FEMORAL NECK. IN THIS CASE IT SEEMS THAT THE SUPPLEMENTARY SCREW IS VERY CLOSE TO OR POSSIBLY BREACHING THE SUPERIOR SURFACE OF THE FEMORAL NECK. WE NEED TO HIGHLIGHT THE FOLLOWING TEXT FROM THE TECHNIQUE: "IF THE SUPPLEMENTARY LAG SCREW IS USED, THE LAG SCREW COULD BE BELOW THE CENTER OF THE FEMORAL NECK AND HEAD. THIS IS ESPECIALLY IMPORTANT IN PATIENTS WITH A NARROW FEMORAL NECK." (PAGE 20 OF TECHNIQUE HF-1501-OPT). [THIS WAS THE FIRST ERROR] 2). THE CEPHALIC SCREW WAS NOT INSERTED FAR ENOUGH INITIALLY. THE IMAGE PROVIDED SHOWS NO SIGN OF A LAG SCREW HAVING PENETRATED FURTHER THAN THE ONE IN SITU. (THIS WOULD BE OBVIOUS BECAUSE OF CAVITATION IN THE BONE CAUSED BY THE SCREW). THEREFORE THE FIRST LAG SCREW INSERTION WAS INCORRECT, IN THAT THE SCREW DID NOT ENGAGE WITH THE NAIL AS DESIGNED, BECAUSE IT WAS NOT INSERTED FAR ENOUGH, AND THE SCREW SLEEVE WAS NOT ENGAGED WITH THE NAIL [THIS WAS THE SECOND ERROR]. THE TIP OF THE SCREW IS A FULL 20 MM FROM THE ARTICULAR SURFACE. WE SHOULD POINT OUT THE FOLLOWING TEXT IN THE TECHNIQUE: "A 3.2MM GUIDE WIRE IS INSERTED THROUGH THE LAG SCREW TROCAR WITH A POWER TOOL. THE POSITION OF THE GUIDE WIRE SHOULD BE CHECKED BY IMAGE INTENSIFIER. THE TIP OF THE WIRE SHOULD BE AT A DISTANCE OF 5-10MM FROM THE ARTICULAR SURFACE AND IT DEFINES THE FINAL POSITION OF THE SCREW." (PAGE 22 OF TECHNIQUE HF-1501-OPT) [THIS WAS THE THIRD ERROR]. SO THE SCREW WAS NOT ENGAGED WITH THE NAIL AND WAS NOT INSERTED CLOSE ENOUGH TO THE ARTICULAR SURFACE FOR RELIABLE STABILITY. 3). IT IS IMPOSSIBLE FOR THE CEPHALIC SCREW TO BE REMOVED WHEN THE ACTION OF FRACTURE COMPRESSION IS BEING CARRIED OUT CORRECTLY. THE SCREW IS INSERTED BY TURNING IT CLOCKWISE. THE ACTION OF COMPRESSION CAN ONLY INSERT THE SCREW FURTHER RATHER THAN REMOVE IT. SEE THE FOLLOWING TEXT FROM THE TECHNIQUE: "COMPRESSION ROD IS INSERTED IN TO THE SCREWDRIVER AND CONNECTED TO THE LAG SCREW BY ROTATING CLOCKWISE ITS SMALL CROWN. COMPRESSION CAN BE ACHIEVED BY ROTATING CLOCKWISE THE BIG CROWN AND THE COMPRESSION AMOUNT CHECKED BY IMAGE INTENSIFIER." (PAGE 28 OF TECHNIQUE). SO, EVERYTHING IS BEING TURNED CLOCKWISE. IN THIS CASE THE CEPHALIC SCREW WAS REMOVED DURING COMPRESSION. FOR THIS TO HAPPEN IT MUST HAVE BEEN TURNED ANTICLOCKWISE. [THIS WAS THE FOURTH ERROR]. THE SCREW WAS REMOVED COMPLETELY DURING THIS PROCESS. HOWEVER, AS STATED ABOVE, THE PROGRESS OF COMPRESSION SHOULD BE OBSERVED ON IMAGE INTENSIFIER. IF HE HAD BEEN DOING THIS IT WOULD HAVE BEEN OBVIOUS THAT THE SCREW WAS BEING EXTRACTED, AND THEREFORE HE WOULD HAVE STOPPED TURNING. [THIS WAS THE FIFTH ERROR] 4). IT WAS FOUND TO BE IMPOSSIBLE TO SEPARATE THE CEPHALIC SCREW FROM THE SCREWDRIVER WITH COMPRESSION ROD. THEREFORE A DIFFERENT CEPHALIC SCREW, LENGTH NOT DEFINED, WAS INSERTED WITH THE RETENTION ROD. BECAUSE OF THE NARROW SIZE OF THIS ROD, IT WAS IMPOSSIBLE TO ADVANCE THE LAG SCREW ANY FURTHER. I SUSPECT THAT THE SURGEON TRIED TO DO THIS, AND THIS IS WHEN THE ROD BROKE. SO THE FINAL SCREW REMAINS UNENGAGED WITH THE NAIL. THE FINAL FIXATION IS NOT AS DESCRIBED IN THE TECHNIQUE, FOR THE REASONS ABOVE. THIS IS BEING REPORTED AS A SERIOUS INJURY, BECAUSE OF ERRORS IN THE SURGERY, AND BECAUSE OF A BROKEN INSTRUMENT BEING LEFT ATTACHED TO THE IMPLANT. THE FIXATION OF THIS FRACTURE IS NOT AS GOOD AS IT SHOULD HAVE BEEN, AND THE RISK OF COMPLICATIONS IS GREATER AS A RESULT". (B)(6) 2017 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "THE TECHNICAL REPORT CONFIRMS THAT ALL THE VARIOUS COMPONENTS OF THIS CHIMAERA NAIL SET HAD BEEN CHECKED FULLY FOR QUALITY AT EACH STEP IN THE MANUFACTURING PROCESS. THE ACTUAL COMPONENTS INVOLVED ARE NOW SO DAMAGED THAT IT IS IMPOSSIBLE TO MAKE A COMMENT ABOUT THEIR CURRENT CONDITION. ALL THE INFORMATION THAT WE HAVE MAKES IT CLEAR THAT THE PREPARATION AND POSITION OF THE CEPHALIC SCREW HOLE WERE INCORRECT. THE SYSTEM FAILED BECAUSE THE DEVICE WAS USED INCORRECTLY. IN PARTICULAR THE RETENTION ROD IS NOT DESIGNED TO BE USED FOR SCREW INSERTION, AND IS NOT ROBUST ENOUGH FOR THIS PURPOSE. IT BROKE BECAUSE IT WAS OVERLOADED BEYOND THE DESIGN CRITERIA. MY CONCLUSIONS AS ALREADY STATED REMAIN THE SAME". FINAL COMMENTS BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS ATTRIBUTABLE TO THE CONDITIONS OF USE OF THE DEVICES. ORTHOFIX (B)(4) WOULD LIKE TO REMIND THAT THE PROPER INSTRUCTIONS FOR USE ARE INCLUDED IN THE OPERATIVE TECHNIQUE, REF: HF-1501-OPT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2017-00063, 9680825-2017-00064 AND 9680825-2017-00065.
THE INFORMATION PROVIDED BY THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: (B)(6), FEMALE; PROBLEM OBSERVED DURING TREATMENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "DURING A CHIMAERA IMPLANT (CODE OF THE NAIL WAS 99-T93125), A LAG SCREW (DEVICE CODE 99-T93790) WAS INSERTED. DURING THE COMPRESSION PHASE, THE SCREW CAME OUT OF THE NAIL. FROM THE INFORMATION AVAILABLE, IT SEEMS TO ME THAT THE WINGS OF THE LAG SCREW DID NOT HOOK-UP TO THE NAIL. ONCE THE SCREW WAS REMOVED, THE SURGEON WAS NOT ABLE TO RELEASE THE SCREW FROM THE SCREWDRIVER THEREFORE THE PROPER INSTRUMENTATION TO RE-IMPLANT THE CEPHALIC SCREW WAS NOT MORE AVAILABLE. TO CONCLUDE THE SURGERY, THE SURGEON DECIDED TO USE THE RETENTION ROD (DEVICE CODE 193282). IN THIS CONDITION HE WAS NOT ABLE TO DO A SUFFICIENT FORCE TO COMPLETE THE SCREW INSERTION. THESE MANEUVERS CAUSED THE BREAKAGE OF THE RETENTION ROD. THE INTERVENTION ENDED WITH THE LAG SCREW IMPLANTED (BUT A PORTION OF THE RETENTION ROD IS STUCK IN IT) ". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT (PORTION OF THE DEVICE WAS LEFT ON PATIENT). THE SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE (USED THE RETENTION ROD CODE 193282). THE EVENT LED TO A CLINICALLY RELEVANT INCREASE OF THE SURGICAL TIME (DELAY TIME NOT QUANTIFIED). A REVISION SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION WAS NOT REQUIRED . COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE (ORTHOFIX (B)(4) RECEIVED AN X-RAY ON NOVEMBER 3, 2017). PATIENT CURRENT HEALTH CONDITION: NO PROBLEM. (B)(4).
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T93790 LOT V1431055 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE (B)(4) COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00062). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193282 LOT 1707942 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE (B)(4) COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00063). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193283 LOT 1708391 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00064). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 193281 LOT 1708106 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (PLEASE REFER TO MFR REPORT 9680825-2017-00065). TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICES, RECEIVED ON NOVEMBER 13 AND NOVEMBER 17, 2017, IS CURRENTLY ON GOING. MEDICAL EVALUATION: 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 TECHICAL INVESTIGATION BECOME AVAILABLE. AS SOON AS FURTHER INFORMATION ON THE CASE IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2017-00063, 9680825-2017-00064 AND 9680825-2017-00065.
THE INFORMATION PROVIDED BY THE SALES MANAGER INDICATES: - HOSPITAL NAME: (B)(6) ; - SURGEON NAME: DR (B)(6) ; - DATE OF INITIAL SURGERY: (B)(6) 2017; - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; - SURGERY DESCRIPTION: FRACTURE TREATMENT; - PATIENT INFORMATION: (B)(6) , FEMALE; - PROBLEM OBSERVED DURING TREATMENT; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; - EVENT DESCRIPTION: "DURING A CHIMAERA IMPLANT (CODE OF THE NAIL WAS 99-T93125), A LAG SCREW (DEVICE CODE 99-T93790) WAS INSERTED. DURING THE COMPRESSION PHASE, THE SCREW CAME OUT OF THE NAIL. FROM THE INFORMATION AVAILABLE, IT SEEMS TO ME THAT THE WINGS OF THE LAG SCREW DID NOT HOOK-UP TO THE NAIL. ONCE THE SCREW WAS REMOVED, THE SURGEON WAS NOT ABLE TO RELEASE THE SCREW FROM THE SCREWDRIVER THEREFORE THE PROPER INSTRUMENTATION TO RE-IMPLANT THE CEPHALIC SCREW WAS NOT MORE AVAILABLE. TO CONCLUDE THE SURGERY, THE SURGEON DECIDED TO USE THE RETENTION ROD ((B)(4)). IN THIS CONDITION HE WAS NOT ABLE TO DO A SUFFICIENT FORCE TO COMPLETE THE SCREW INSERTION. THESE MANEUVERS CAUSED THE BREAKAGE OF THE RETENTION ROD. THE INTERVENTION ENDED WITH THE LAG SCREW IMPLANTED (BUT A PORTION OF THE RETENTION ROD IS STUCK IN IT) ". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT (PORTION OF THE DEVICE WAS LEFT ON PATIENT). - THE SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE (USED THE RETENTION ROD CODE 193282) - THE EVENT LED TO A CLINICALLY RELEVANT INCREASE OF THE SURGICAL TIME (DELAY TIME NOT QUANTIFIED). - A REVISION SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE (ORTHOFIX SRL RECEIVED AN X-RAY ON (B)(4) 2017) - PATIENT CURRENT HEALTH CONDITION: NO PROBLEM. MANUFACTURER REFERENCE NUMBER: (B)(4) .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849268 | CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE | CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE | HSB | ORTHOFIX SRL | 99-T93790 | V1431055 | 18054242514749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |