BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 5585157 · Received April 18, 2016

    Report

    Report Number
    3000270450-2016-10098
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    March 22, 2016
    Report Date
    April 1, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN DATE OF OCTOBER 2025 WAS REPORTED IN ERROR ¿ THE DEVICE WAS NOT RETURNED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT AGE & WEIGHT NOT PROVIDED. ADDITIONAL PRODUCT CODES: MNH MNI KWQ KWP. (B)(4). DATE RETURNED TO MANUFACTURER. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 05 NOVEMBER 2015 EXPIRY DATE: 01 OCTOBER 2025. 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. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: NON-STERILE 04.632.000 / 9896127 WAS MANUFACTURED IN US, (B)(4), MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 04-SEP-2015 PART #: 04.632.000, LOT#: 9896127 (NON-STERILE) - TI MATRIX LOCKING CAP. 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. 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

    THIS IS REPORT 1 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A SURGERY IN SEGMENT L5/S1 ON (B)(6) 2016 WITH MATRIX 5.5. BECAUSE OF HER OBESITY AND THEREFORE POOR FLUOROSCOPY THERE HAD TO BE A REVISION SURGERY ON (B)(6) 2016. FOR LOCKING CAP REMOVAL THE SURGEON USED THE TECHNIQUE AS IN THE TECHNIQUE GUIDE DESCRIBED (TORQUE LIMITING HANDLE, SCREWDRIVER SHAFT 03.632.401 AND COUNTER TORQUE 03.632.049). IN POSITION L5 LEFT THE LOCKING CAP DID NOT LOOSEN EVEN AFTER TURNING THE T-HANDLE MORE THAN TEN TIMES CLOCK- AND COUNTERCLOCKWISE. THEREFORE THE SURGEON DECIDED TO USE THE OPERACE SET. THE OPERACE SET HAS NO TORQUE LIMITER, SO THE TIP OF THE SCREWDRIVER BROKE AND REMAINED IN THE LOCKING CAP. SO THEY HAD TO LEAVE THE LEFT SIDE AS IT HAD BEEN IMPLANTED. THE TIP OF THE OPERACE SCREWDRIVER REMAINED IN THE PATIENT. WHEN THE SURGEON TRIED TO LOOSEN THE LOCKING CAP IN L5 RIGHT HE AGAIN USED THE ORIGINAL SURGERY TECHNIQUE. ALTHOUGH HE USED THE TORQUE LIMITING HANDLE THE TIP OF THE SCREWDRIVER 03.632.401 BROKE, BUT COULD BE REMOVED. BESIDES THAT HE THEN COULD REMOVE THE TWO SCREWS ON THE RIGHT SIDE AND PLACE NEW ONES CORRECTLY. THE PATIENT IS FINE AND DOES NOT COMPLAIN ABOUT PAIN. SURGEON IS SATISFIED WITH THE OUTCOME OF THIS REVISION. THE SURGERY WAS PROLONGED. THIS COMPLAINT INVOLVES 1 PARTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240360 TI MATRIX LOCKING CAP ORTHOSIS, SPINAL PEDICLE, FIXATION, FOR DDD NKB SYNTHES SELZACH 9714656

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention