ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Report
- Report Number
- 8030965-2019-59982
- Event Type
- Injury
- Date Received
- January 16, 2019
- Date of Event
- December 1, 2018
- Report Date
- December 26, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
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. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. RETURNED DEVICE IS THE ONE THAT MALFUNCTIONED DURING IMPLANT PROCEDURE ON DEC 23, 2018. IT IS UNKNOWN IF THE PAIN IS ASSOCIATED WITH IMPLANTED DEVICES OR THE ONE THAT COULD NOT BE IMPLANTED AND HAD TO BE REMOVED DURING PROCEDURE ON DEC 23, 2018. E1, E3: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. H3, H6: THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. H11 CORRECTED DATA: G3 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.
THIS IS REPORT 5 OF 7 FOR (B)(4).
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE THREADS OF THE TWO (2) PEDICLE MATRIX SCREWS, AND THREE (3) LOCKING CAPS WERE PEELED OR TORN, ONE (1) UNKNOWN ROD WAS DAMAGED, AND IT COULD NOT BE REMOVED AFTER LOCKING. THE SURGEON HAD TO REMOVE THE DEVICES WITH AN EXTERNAL FORCE. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER SAME DEVICES: PATIENT WAS IMPLANTED WITH AN UNKNOWN ROD, TWO (2) PEDICLE MATRIX SCREWS, AND THREE (3) LOCKING CAPS. THE PROCEDURE TIME PROLONGED TO THREE HOURS. ON AN UNKNOWN DATE POST IMPLANT PROCEDURE, THE PATIENT FELT PAIN. THERE WAS NO INFORMATION ABOUT THE REVISION SURGERY. THIS COMPLAINT (B)(4) CAPTURES THE POST-OPERATIVE PAIN EVENT, WHILE (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT. THIS IS REPORT 5 OF 7 FOR (B)(4).
THIS REPORT IS FOR AN UNKNOWN RODS: MATRIX/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT FELT PAIN AFTER THE OPERATION. INITIALLY, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH THE AN UNKNOWN ROD, TWO (2) PEDICLE MATRIX SCREWS, AND THREE (3) LOCKING CAP ON (B)(6) 2018. THERE WAS NO INFORMATION ABOUT THE REVISION SURGERY AS OF THIS TIME THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) UNK - RODS: MATRIX. THIS REPORT IS 5 OF 5 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47661 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |