BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM COLLAR FOR TRANS-CONNECTOR CLAMP

    MDR report key: 4190980 · Received October 21, 2014

    Report

    Report Number
    2530088-2014-10323
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DISC COLLAPSE AT LEVEL L1. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE REVIEW FOUND ONE NONCONFORMING REPORT FOR PART NUMBER 298.811, LOT # 5687361, MRR # 158767 WAS ISSUED AT INSPECTION DUE TO OVERLAY FAILURE. THIS WAS AN INSPECTOR ERROR DUE TO IMPROPER TECHNIQUE, THE TECHNIQUE WAS REVIEWED WITH THE INSPECTOR AND ALL PARTS CONFORMED TO SPECIFICATION. IN ADDITION, MRR# 143734 WAS ISSUED TO RAW MATERIAL # 11009 LOT # 4262969 DUE TO BAR LENGTH OVERSIZE. SPECIFICATIONS DID NOT INCLUDED A LENGTH REQUIREMENT WHEN THE ORDER WAS PLACED, AND THE FINAL PART FEATURES WERE NOT AFFECTED BY THE BAR LENGTH. THESE NON-CONFORMANCES ARE NOT RELATED TO THE COMPLAINT CONDITION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 A PATIENT PRESENTED WITH A SPINE BURST FRACTURE AT LEVEL L1. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2014. DURING INITIAL PROCEDURE THE SURGEON WENT IN WITH THE IMPRESSION THAT AN ANTERIOR FUSION MAY BE NEEDED AS WELL; HOWEVER, ONLY A POSTERIOR FUSION WAS PERFORMED. SURGEON USED IMPLANTS FROM THE UNIVERSAL SPINE SYSTEM FRACTURE SYSTEM; RODS, SCREWS AND CLAMPS AT T12 - L2 LEVELS. POST OPERATIVELY THE PATIENT¿S DISK COLLAPSED AT L1 OVER THE NEXT MONTH. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. IT WAS REPORTED THAT DURING REVISION SURGERY, FOUR SCHANZH SCREWS HAD PULLED OUT AT T12- L2 LEVELS FROM THE ORIGINAL CONSTRUCT. PATIENT WAS REVISED AT T12-L2 LEVELS WITH EXPEDIUM PEDICEL SCREWS AND RODS WITH EXPANDABLE LATERAL CAGE PLACED AT L1 LEVEL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS OUTCOME WAS GOOD. THIS IS REPORT NUMBER 16 OF 18 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670104 6.0MM COLLAR FOR TRANS-CONNECTOR CLAMP ORTHOSIS, SPINAL PEDICLEFIXATION, FOR DDD NKB SYNTHES BRANDYWINE 5687361

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention