BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 4 LEVEL/60MM

    MDR report key: 12180371 · Received July 16, 2021

    Report

    Report Number
    2939274-2021-04133
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KWQ
    UDI-DI
    10705034781006
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. H3, H4, H6: PART: 450.181, SYNTHES LOT: 4172607, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: SEPTEMBER 19, 2000, MANUFACTURED BY: SYNTHES BRANDYWINE. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE TI CSLP VARIABLE ANGLE 4 LEVEL/60MM WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE DEVICE SHOWED THAT ONE OF THE TEN BUSHINGS FALL OFF. NO OTHER DEFECT WAS OBSERVED. FUNCTIONAL TEST: DURING A FUNCTIONAL ASSESSMENT ATTEMPTS WERE MADE TO RE-ATTACH THE BUSHING BACK BUT IT WAS UNSUCCESSFUL. THE BUSHING WAS NOT ABLE TO BE ASSEMBLE WITH THE PLATE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO THE DEVICE ASSEMBLY AND GEOMETRY LIMITS ABILITY TO ACCURATELY DIMENSIONALLY INSPECT THE RELEVANT FEATURES. ALSO, SOME RELEVANT FEATURES WERE NO LONGER ABLE TO BE CHECKED POST SLOTTING AND BLASTING. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE BUSHING FELL OFF THE PLATE AND WAS UNABLE TO BE RE-ASSEMBLED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISKECTOMY ON (B)(6) 2021, THE SURGEON WAS USING A 60MM CSLP PLATE AND THE VARIABLE ANGLE BUSHING POPPED OUT WHILE INSERTING A SCREW. A NEW SET WAS OPENED AND A NEW 60MM CSLP PLATE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FIVE (5) MINUTES. THIS REPORT IS FOR A TITANIUM (TI) CERVICAL SPINE LOCKING PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081183 TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 4 LEVEL/60MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 450.181 4172607 10705034781006

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR UNKNOWN SCREWS| UNKNOWN SCREWS