BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 7307902 · Received March 1, 2018

    Report

    Report Number
    8030965-2018-51618
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    UDI-DI
    07611819414600
    PMA / PMN Number
    K151276
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NO.: 03.812.003. LOT NO.: 8830007. MANUFACTURING LOCATION: HAEGENDORF. RELEASE TO WAREHOUSE DATE: 13.MAY.2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: THE COUPLING KNOB AT THE END OF THE APPLICATOR INNER SHAFT 03.812.003 IS BROKEN OFF AS COMPLAINED AND THE COMPLAINT THEREFORE IS CONFIRMED. THE BROKEN OFF KNOB IS AVAILABLE FOR INVESTIGATION. THE DEVICE IS IN A COMMON CONDITION WITH SOME WEAR AND TEAR. THE RELEVANT DIMENSIONS AND THE RADIUS AT THE FRACTURED FACE CANNOT BE VERIFIED ANYMORE BECAUSE OF THE EXISTING DAMAGE AND DEFORMATION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS MANUFACTURED IN MAY 2014 ACCORDING TO THE SPECIFICATIONS. WITH STAINLESS STEEL 1.4028 THE CORRECT MATERIAL WAS USED. THE HARDNESS WAS TESTED WITH HARDNESS TESTER REFERENCE NO. 13732-H AND CORRESPONDED TO THE SPECIFICATION OF 48 +4 / 0 HRC AS DEFINED IN DRAWING. APPROPRIATE ACTIONS HAVE BEEN INITIATED/TAKEN TO ADDRESS THE MATTER. WE ARE NOT ABLE TO DETERMINE AN EXACT CAUSE OF BREAKAGE FOR THIS SEVERAL YEARS OLD APPLICATOR INNER SHAFT. MULTIPLE CIRCUMSTANCES POSSIBLY LED TO A DAMAGE OF APPLICATOR INNER SHAFTS: NONCOMPLIANCE WITH SURGICAL TECHNIQUE. EXCESSIVE APPLICATION OF FORCE. NOT REPLACING OF APPLICATOR INNER SHAFT DURING FUNCTION CONTROL NEVERTHELESS OF EXISTING WEAR AND DAMAGE; SEE SURGICAL TECHNIQUES FOR T-PAL SURGICAL TECHNIQUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS APPROPRIATE. 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER APPLICATOR INNER SHAFT WAS USED IN A SURGICAL PROCEDURE FOR SPINAL CANAL STENOSIS AT L3 TO L5 ON (B)(6) 2018. THE SAME DEVICE WAS USED FOR ANOTHER PROCEDURE ON (B)(6) 2018 AND IT WAS THEN IT WAS NOTED TO BE BROKEN. THE (B)(6) 2018 PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150881 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 8830007 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1