BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANS-CONNECTOR CLAMP BODY

    MDR report key: 4190881 · Received October 21, 2014

    Report

    Report Number
    2530088-2014-10325
    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

    ADDITIONAL PATIENT ID: (B)(6). ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. (B)(6) - 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 IDENTIFIED REWORK PERFORMED ON RAW MATERIAL (B)(4), COMPLETED ON 11-08-05 AND 11-10-05, LOT #3158517 TO CORRECTLY IDENTIFY AND REMARK RAW MATERIAL. THIS REWORK DOES NOT AFFECT REGULATORY ASPECTS OF MATERIAL. DHR REVIEW IDENTIFIED MRR #(B)(4) FOR PART NO. 11013, LOT #3158517 FOR RECEIVED LENGTHS BEING TOO LONG. THIS MATERIAL WAS PURCHASED PRIOR TO CHANGE TO LIMIT LENGTH. THIS MRR WILL HAVE NO AFFECT ON COMPLAINT CONDITION BECAUSE MATERIAL CONFORMS TO SPECIFICATION. DHR REVIEW IDENTIFIED MRR #(B)(4) FOR PART NO. 11007, LOT #5091316 FOR SPECIFICATION FOR IRON NOT ON CERTIFICATION AND UTS WAS OUT OF SPECIFICATION. CERT WAS CORRECTED AND IT WAS ESTABLISHED THAT SINCE A MINIMUM OF (B)(4) ELONGATION WAS MET, MATERIAL IS ACCEPTABLE. THIS MRR WILL HAVE NO AFFECT ON COMPLAINT CONDITION BECAUSE MATERIAL CONFORMS TO SPECIFICATION. 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 REPORT 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 18 OF 18 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669938 TRANS-CONNECTOR CLAMP BODY ORTHOSIS, SPINAL PEDICLEFIXATION, FOR DDD NKB SYNTHES BRANDYWINE 5707492

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention