TI MATRIXRIB UNIVERSAL PLATE 8 HOLES-STERILE
Report
- Report Number
- 8030965-2018-54707
- Event Type
- Injury
- Date Received
- June 28, 2018
- Report Date
- June 12, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- UDI-DI
- 07611819341258
- PMA / PMN Number
- K081623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. CORRECTED DATA: THERAPY DATE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IMPLANT DATE CORRECTED TO (B)(6) 2016. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. UPDATE EVENT INFO. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. UPDATED CONCOMITANT DEVICES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT ETHNICITY IS UNKNOWN. PART: 04.501.009S; LOT: 9719060; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: NOVEMBER 20, 2015; EXPIRY DATE: NOVEMBER 01, 2025. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO (B)(4) SPECIFICATION FOR IMPLANTS FOR SURGERY. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RISK ASSESSMENT FOR MATRIXRIB ADDRESSES THE HAZARD ¿PLATE BREAKS POST-OPERATIVELY¿. THIS COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS FURTHER PROVIDED THAT ORIGINALLY, THE PATIENT WAS IMPLANTED WITH SYNTHES RIB FIXATION SYSTEM ON DECEMBER 17, 2016, FOLLOWING A FALL IN WHICH THE PATIENT SUSTAINED LEFT SIDED FRACTURES 4TH TO 11TH. DUE TO THE ONGOING PAIN AND SHORTNESS OF BREATH, THE SURGERY TOOK PLACE. ON (B)(6) 2017, THE PATIENT BEGAN TO DEVELOP PAIN AND BRUISING TO THE CHEST AREA AND IT WAS DISCOVERED THROUGH CHEST X-RAY AND CT SCAN THAT A LUMP HAD APPEARED AROUND THE SCAR FROM LEFT-SIDED ROB FIXATION AND THE MATIXRIB UNIVERSAL PLATE HAD FRACTURED. ON (B)(6) 2017, THE PATIENT WAS READMITTED IN THE HOSPITAL. ON AUGUST 11, 2017, THE PATIENT UNDERWENT REMOVAL OF SYNTHES RIB FIXATION SYSTEM DUE TO LUMP APPEARED AROUND THE SCAR FROM LEFT-SIDED RIB FIXATION AND THE MATIXRIB UNIVERSAL PLATE HAD FRACTURED OVERLYING THE 7TH RIB FRACTURE. ALSO, THE PATIENT SUSTAINED HEMATOMA OVER THE CHEST WALL AREA AT THE SITE OF THE PLATE.
(B)(6) 2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF SYNTHES RIB FIXATION SYSTEM DUE TO A LUMP THAT APPEARED AROUND THE SCAR FROM THE LEFT-SIDED RIB FIXATION AND THE MATIX RIB UNIVERSAL PLATE, WHICH HAD FRACTURED OVERLYING THE 7TH RIB. IN ADDITION, THE PATIENT SUSTAINED A HEMATOMA OVER THE CHEST WALL AREA AT THE SITE OF THE PLATE. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH SYNTHES RIB FIXATION SYSTEM ON (B)(6) 2016, FOLLOWING A FALL IN WHICH THE PATIENT SUSTAINED LEFT SIDED FRACTURES 4TH TO 11TH. SURGERY WAS PERFORMED DUE TO THE ONGOING PAIN AND SHORTNESS OF BREATH. ON (B)(6) 2017, THE PATIENT BEGAN TO DEVELOP PAIN AND BRUISING TO THE CHEST AREA AND IT WAS DISCOVERED THROUGH CHEST X-RAY AND CT SCAN THAT A LUMP HAD APPEARED AROUND THE SCAR FROM LEFT-SIDED RIB FIXATION AND THE MATIX RIB UNIVERSAL PLATE HAD FRACTURED. (B)(6) 2017, THE PATIENT WAS READMITTED IN THE HOSPITAL. CONCOMITANT DEVICES REPORTED: MATRIXRIB LOCK SCREW (PART #: 04.501.020.01S, LOT #, L137993,L044318,9749851,L060379,9772058,L137916,L061880,L066835,9682600, QUANTITY #: 16) MATIX RIB UNIVERSAL PI TAN (PART #: 04.501.009S, LOT #: L049683, L013135, QUANTITY #: 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE.
CONCOMITANT DEVICES REPORTED: MATRIXRIB UNIVERSAL PL 8HO TAN (PART # 04.501.009S, LOT # L049683, QUANTITY 1). MATRIXRIB UNIVERSAL PL 8HO TAN (PART # 04.501.009S, LOT # L013135, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # L066835, QUANTITY 3), LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # L061880, QUANTITY 1), LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # 9682600, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # 9772058, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # L060379, QUANTITY 4). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # L137993, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # L044318, QUANTITY 2). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # 9749851, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # L137916, QUANTITY 1). LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.020.01S, LOT # UNKNOWN, QUANTITY 1).
THIS PATIENT INFORMATION IS UNKNOWN. THE PLATE FRACTURED APPROXIMATELY 6 MONTHS LATER, EXACT DATE IS UNKNOWN. IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2016. EXPLANTED ON AN UNKNOWN DATE IN (B)(6) 2017. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS TREATED ORIGINALLY IN (B)(6) 2016 FOR MULTIPLE RIB FRACTURES USING OUR MATRIX RIB FIXATION PLATES. THE SURGEON USED THREE PLATES. THE PATIENT THEN HAD ONE PLATE FRACTURE APPROXIMATELY 6 MONTHS LATER. THE BROKEN PLATE WAS REVISED IN (B)(6) 2017, THE OTHER TWO PLATES WERE LEFT IN PLACE. CONCOMITANT DEVICES REPORTED: UNKNOWN MATRIXRIB PLATES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2); LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # L066835, QUANTITY 3), LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # L061880, QUANTITY 1), LOCK SCREW Ø2.9 SELF-TAP L12 TAN (PART # 04.501.022.01S, LOT # 9682600, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI MATRIXRIB UNIVERSAL PLATE 8 HOLES-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489053 | TI MATRIXRIB UNIVERSAL PLATE 8 HOLES-STERILE | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | 9719060 | 07611819341258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | THERAPY DATE: (B)(6) 2016 |