BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MIRS LOCKING CAP

    MDR report key: 6778108 · Received August 9, 2017

    Report

    Report Number
    1000562954-2017-10167
    Event Type
    Injury
    Date Received
    August 9, 2017
    Report Date
    July 10, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    K113044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF DEVICE LOOSENING IS NOT KNOWN. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. UDI: (B)(4) EXPIRATION UNKNOWN LOT NUMBER UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL CONTACT TELEPHONE: (B)(6). (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE PARTS WERE NOT RETURNED SO A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE INVESTIGATION HAS SHOWN THAT THE COMPLAINED IMPLANTS (PART NUMBERS 04.631.500 AND 04.631.502S ) ARE PART OF A PRODUCT REMOVAL, WHICH WAS STARTED IN SEPTEMBER 2012. THE PRODUCT REMOVAL HAD BEEN INITIATED FOLLOWING A DETAILED INVESTIGATION IN RESPONSE TO REPORTED COMPLAINTS OF POST-OPERATIVE LOCKING CAP LOOSENING. EVALUATION OF THE COMPLAINTS AND INVESTIGATION HAS DETERMINED THAT IF THE CONSTRUCT IS MISALIGNED DURING FINAL TIGHTENING, THE POTENTIAL EXISTS FOR LOCKING CAPS TO LOOSEN POSTOPERATIVELY IN CERTAIN SITUATIONS. THIS PRESENTS THE POTENTIAL RISK FOR REVISION/ REOPERATION FOR THE PATIENT. IT WAS DETERMINED THAT THE ROOT CAUSE IS ROD MISALIGNMENT THROUGH THE POLYAXIAL HEAD DURING THE FINAL TIGHTENING RESULTING IN POSSIBLE BACKING OUT OF LOCKING CAP. THIS WAS DETERMINED TO BE TECHNIQUE RELATED. IT WAS DETERMINED THE TECHNIQUE GUIDE DID NOT PROVIDE SUFFICIENT DETAIL TO MITIGATE THE RISK OF POST-OPERATIVE LOCKING CAP BACK OUT. A REVISED TECHNIQUE GUIDE IS AVAILABLE NOW PROVIDING THE USER WITH MORE DETAILED INSTRUCTIONS TO ENSURE PROPER ALIGNMENT OF THE ROD DURING FINAL TIGHTENING. CORRECT CONCOMITANT DEVICES. 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

    ADDITIONAL INFORMATION REGARDING PROCEDURE ADDED, DESCRIPTION AND CONCOMITANT DEVICE LIST UPDATED. 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 PATIENT WAS IMPLANTED WITH TWO (2) RODS, UNKNOWN NUMBER OF MINIMALLY INVASIVE REDUCTION SCREWS (MIRS) AND UNKNOWN NUMBER OF MIRS LOCKING CAPS AT UNKNOWN LEVELS ON (B)(6) 2012. ON UNKNOWN DATE X-RAYS REVEALED THAT SOME OF THE LOCKING CAPS HAD LOOSENED. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION SURGERY. IT IS NOT KNOWN IF ANY ADDITIONAL HARDWARE WAS IMPLANTED AT THAT TIME OR IF ALL HARDWARE WAS SIMPLY REMOVED. CONCOMITANT DEVICES REPORTED: ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2), MIRS POLYAXIAL SCREW BODY TAN (PART# 04.631.500, LOT# 7951942, QUANTITY 2), MIRS POLYAXIAL SCREW BODY TAN (PART# 04.631.500, LOT# 7918298, QUANTITY 2), MIRS POLYAXIAL SCREW BODY TAN (PART# 04.631.500, LOT# 7918302, QUANTITY 5), MIRS POLYAXIAL SCREW BODY TAN (PART# 04.631.500, LOT# 7964212, QUANTITY 1). THIS REPORT IS FOR ONE (1) MIRS LOCKING CAP. THIS IS REPORT 6 OF 10 FOR (B)(4).

    Description of Event or Problem · 1

    CORRECT CONCOMITANT DEVICES: RODS (PART/LOT UNKNOWN, QUANTITY 2); PERFORATED MATRIX PEDICLE SCREWS (PART/LOT UNKNOWN, QUANTITY 10).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A MINIMALLY INVASIVE REDUCTION SYSTEM (MIRS) PROCEDURE AT T9-T12, L2, AND L3 ON (B)(6) 2012. ON UNKNOWN DATE IT WAS DETERMINED ALL OF THE LOCKING CAPS WERE LOOSE AND SOME OF THEM WERE ALSO DETACHED FROM THE SCREW HEAD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE LOCKING CAPS AND BOTH RODS. EIGHT (8) OF THE SCREWS WERE COMPLETELY REMOVED AND REPLACED WITH MATRIX SCREWS. THE SCREW HEAD ONLY WAS REPLACED WITH MATRIX SCREW HEADS ON THE REMAINING TWO (2) SCREWS. CONCOMITANT DEVICES REPORTED: MIRS POLYAXIAL SCREW BODY (04.631.500, LOT 7951942, QUANTITY 2), MIRS POLYAXIAL SCREW BODY (04.631.500, LOT 7918298, QUANTITY 2), MIRS POLYAXIAL SCREW BODY (04.631.500, LOT 7918302, QUANTITY 5), MIRS POLYAXIAL SCREW BODY (04.631.500, LOT 7964212, QUANTITY 1), ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) MIRS LOCKING CAP. THIS IS REPORT 6 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561795 TI MIRS LOCKING CAP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART# 04.631.500, LOT# 7918298, QUANTITY 2| PART# 04.631.500, LOT# 7918302, QUANTITY 5| PART# 04.631.500, LOT# 7951942, QUANTITY 2| PART# 04.631.500, LOT# 7964212, QUANTITY 1| TWO (2) UNKNOWN RODS