BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 4092476 · Received September 16, 2014

    Report

    Report Number
    3003875359-2014-10270
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PD EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE NO DEVIATION ON THE PARTS COULD BE DETECTED. THE RECEIVED ASSEMBLY IS FUNCTIONING. PARTS CAN BE SHIPPED BACK. THE COMPLAINT DESCRIPTION IS CONFUSING AND/OR NOT CONSISTENT, BECAUSE NO ARTICLE NUMBER OF A TRIAL IMPLANT WAS MENTIONED. ADDITIONALLY, DETACHABLE TRIALS ARE NOT REGISTERED IN (B)(4), ONLY NON-DETACHABLE TRIAL IMPLANTS ARE REGISTERED (SEE ATTACHED EMAIL). THEREFORE, THE IMPLANT ITSELF COULD NOT GET DETACHED. MOST LIKELY THE SURGEON DID NOT FOLLOW THE INSERTION ANGLE SHOWN IN SURGICAL TECHNIQUE GUIDE 03.001.088 PAGE 16, PICTURE 1. IF THE INSERTION ANGLE IS TOO SMALL, DETACHING CAN BE HINDERED. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT THE SURGEON COULD NOT REMOVE THE APPLICATOR FROM THE TRIAL IMPLANT AFTER HE FOLLOWED THE PROCEDURE ACCORDANCE WITH THE TECHNIQUE GUIDE. AFTER SEVERAL TIMES OF REMOVAL APPROACHES OF THE SURGEON, THE APPLICATOR FINALLY CAME OFF THE TRIAL IMPLANT. THE CAGE THAT WAS USED WAS A 8MM. THERE WAS A 10 MINUTE DELAY REPORTED. THIS IS REPORT NUMBER 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573442 T-PAL SPACER APPLICATOR KNOB MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8475044

    Patients

    Seq Age Sex Outcome Treatment
    1