MIS SINGLE INNER SETSCW
Report
- Report Number
- 1526439-2021-00410
- Event Type
- Injury
- Date Received
- March 8, 2021
- Report Date
- February 8, 2021
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- NKB
- UDI-DI
- 10705034121192
- PMA / PMN Number
- K160904
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- THE COMPLAINT IS BEING CONFIRMED FOR MIS SINGLE INNER SETSCW (PART# 186715000, LOT# 192987) AS THE INNER SET SCREWS WERE BACKED OUT FROM THEIR ORIGINAL POSITION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE DHR OF PRODUCT CODE: 186715000. LOT : 192987. WAS ELECTRONICALLY REVIEWED AND THE NON-CONFORMANCE NR-0155755. HAS BEEN OBSERVED DURING THE MANUFACTURING PROCESS WITH NO LINK WITH COMPLAINT DESCRIPTION. THE PRODUCT WAS RELEASED ON: 02.05.2018. 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: B6, D4 H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE LOOKS GOOD WITHOUT ANY PHYSICAL DAMAGE. THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE X-RAY IMAGES PROVIDED SHOWS THAT THE POLYAXIAL SCREWS WERE NOT MOVED FROM THEIR ORIGINAL POSITION. COMPLETE FUNCTIONAL TESTING OF THE RECEIVED DEVICE CANNOT BE PERFORMED. HOWEVER, ALL THE INNER SET SCREWS RECEIVED WERE SCREWED INTO THE POLYAXIAL SCREW RECEIVED AND REMOVED WITHOUT ANY ISSUES. DIMENSIONAL INSPECTION OF THE RECEIVED SET SCREW WAS PERFORMED. THE INTERNAL THREADED DIAMETER OF THE HEAD OF THE POLYAXIAL SCREW MEASURED TO BE WITHIN SPECIFICATION AS PER THE DRAWING. THE RELEVANT DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED AS NO FUNCTIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. H6: HEALTH EFFECT - CLINICAL CODE APPROPRIATE TERM/CODE NOT AVAILABLE (E2402) USED TO CAPTURE INJURY (E20). H6: CUSTOMER QUALITY INVESTIGATION: THE IMPLANT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S).THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION(S) OF MIGRATION COULD NOT BE CONFIRMED AS THE IMAGE(S) PROVIDED DID NOT SHOW ANY SCREWS MIGRATING FROM THE SPINE. AS THE IMPLANT(S) WAS NOT RETURNED AN AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE(S). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS IT WAS UNCONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.
ADDITIONAL PROCODES: KWP, KWQ, MNH, MNI, OSH. DATE OF IMPLANTATION IS AN UNKNOWN DATE IN 2018. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. 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.
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 9 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331305 | MIS SINGLE INNER SETSCW | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | MEDOS INTERNATIONAL SÃ RL CH | 186715000 | 192987 | 10705034121192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | MIS CANN POLY SCW 5X35MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS CANN POLY SCW 5X35MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS CANN POLY SCW 6X40MM,TI| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW| MIS SINGLE INNER SETSCW |