BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL PROTI 12X8X32 MM

    MDR report key: 13938132 · Received March 29, 2022

    Report

    Report Number
    3012966183-2022-00008
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    June 22, 2021
    Report Date
    March 29, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR WAS REVIEWED FOR LOT 1120022. THIS LOT WAS MANUFACTURED, INSPECTED, PACKAGED, AND STERILIZED PER SPECIFICATIONS. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS LIT. A VISUAL REVIEW OF THE PRODUCT CONFIRMED THE COMPLAINT THAT THE TLIF IMPLANT FRACTURED THROUGH THE SIDEWALL OF THE IMPLANT PAST THE CONNECTION TO THE INSERTER . MINOR DAMAGE TO THE SUPERIOR AND INFERIOR COATED ENDPLATES WAS NOTED, HOWEVER NO CONCLUSION COULD BE MADE AS TO WHETHER THE DAMAGE WAS A RESULT OF ATTEMPTED IMPLANTATION OR DECONTAMINATION PRIOR TO RETURN. AN INSERTER WAS RETURN WITH THE IMPLANT, HOWEVER THE TYBER MEDICAL IS NOT THE OEM OF THE INSTRUMENT AND WAS NOT ABLE TO DETERMINE IF THE INSTRUMENT WAS IN SPECIFICATION. THE INSTRUMENT APPEARED TO BE FUNCTIONING AS INTENDED. THE RESULTS OF THE INVESTIGATION SUGGEST THAT THE ROOT CAUSE OF THE FAILURE WAS A USER ERROR APPLICATION OF EXCESSIVE FORCE AS DESCRIBED IN THE COMPLAINT REPORT. PROPER TRIALING AND DISC PREPARATION ARE ESSENTIAL PRIOR TO IMPLANT INSERTION. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A TLIF TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. AFTER THE CAGE WAS DEPLOYED, THE SURGEON STARTED TURNING THE CAGE FOR OBTAINING MORE APPROPRIATE POSITION WITH THE HELP OF A HAMMER. AS HE TAPPED THE CAGE FORCEFULLY, IT BROKE OFF. HE DECIDED TO LEAVE APPROXIMATELY HALF THE SIZE OF THE CAGE IN THE PATIENT'S BODY AND COMPLETED THE PROCEDURE LESS THAN 30-MINUTE SURGICAL DELAY. THE SURGEON COMMENTED THE FOLLOWING: THE POSSIBLE CAUSES FOR THE EVENT: THE PATIENT HAD ROBUST BONE. HE TURNED THE CAGE IN QUESTION WHICH WAS DEPLOYED AT SLIGHTLY ANTERIOR POSITION COMPARED THE TRIAL IMPLANT. THE PATIENT HAS NOT SHOWN ANY ADVERSE EFFECT. NO FURTHER TREATMENT IS PLANNED. NO FURTHER INFORMATION IS AVAILABLE. THIS(B)(4) DEAL WITH THE IDENTICAL EVENT. (B)(4): SPINE ITEM 2. (B)(4): SYNTHES ITEMS CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760744 T-PAL PROTI 12X8X32 MM INTERBODY SPACERS MAX TYBER MEDICAL 108812208 1120022

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other