BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM

    MDR report key: 6166105 · Received December 12, 2016

    Report

    Report Number
    2520274-2016-15654
    Event Type
    Injury
    Date Received
    December 12, 2016
    Report Date
    November 18, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKG
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR ONE (1) SYNAPSE 3.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM OF UNKNOWN LOT. ADDITIONAL PRODUCT CODE: KWP. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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. 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

    PART 04.614.030, SYNTHES LOT 9932235: RELEASE TO WAREHOUSE DATE: OCTOBER 23, 2015. MANUFACTURED BY (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 NARRATIVE: ADDITIONAL PRODUCT CODES: MNH, MNI. A MANUFACTURING EVALUATION WAS COMPLETED: PRODUCT WAS RECEIVED WITH NECK OF SCREW FRACTURED WITH THE BODY ASSEMBLY FIRMLY ATTACHED TO SPHERICAL DIAMETER OF THE SCREW AND ROD (CONCOMITANT PART OF CONSTRUCT) WITH BONE THREAD DETACHED. THE DIAMETER OF SCREW IN COMPLAINT COULD NOT BE MEASURED BECAUSE OF DAMAGE; BUT, THE CONCOMITANT SCREW (WITH SAME LOT NUMBER) NECK DIAMETER CONFORMS PER TOP LEVEL PRINT SPECIFICATIONS. NO SCRAP WAS REPORTED AT DEVICE HISTORY RECORD (DHR) REVIEW. RAW MATERIAL COULD NOT BE MEASURED BECAUSE THERE IS NOT ADEQUATE SURFACE AREA FOR THE MATERIAL ANALYZE TO GET A READING, BUT WAS CONFIRMED AS GOOD IN DHR REVIEW. COMPLAINT IS UNCONFIRMED FROM A MANUFACTURING PERSPECTIVE. DISASSEMBLY WOULD NOT HELP TO GET A BETTER READING FOR RAW MATERIAL OR NECK DIAMETER DUE TO SURFACE AREA AND HOW AND WHERE THE FRACTURE OCCURRED. THESE CONDITIONS ARE NOT MANUFACTURING RELATED. FEATURES RELEVANT TO COMPLAINT CONDITION ARE UNOBTAINABLE, BUT MEET SPECIFICATION PER DHR; BUT, SCREW IS FRACTURED, COMPLAINT IS CONFIRMED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED. 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 THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO A SYNAPSE SCREW BREAKAGE. THE INITIAL IMPLANT DATE OCCURRED ON (B)(6) 2016 FOR AN UNKNOWN PROCEDURE. THE SYNAPSE SCREW BROKE ON AN UNKNOWN DATE POST-OPERATIVELY AS DETERMINED BY X-RAYS TAKEN ON AN UNKNOWN DATE. NO DELAY TO SURGERY TIME. PATIENT OUTCOME WAS LISTED AS STABLE FOLLOWING THE REVISION SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT PARTS INVOLVED: SYNAPSE SCREW (PART 04.614.030, LOT 9932235, QUANTITY 1); ROD (PART 498.957, LOT 3325427, QUANTITY 1); ROD (PART/LOT UNKNOWN, QUANTITY 1); END CAP (PART 04.614.508, LOT 7949903, QUANTITY 1); END CAP (PART 04.614.508, LOT 7983044, QUANTITY 1); TRANSVERSE CONNECTOR (PART 04.614.513 OR 04.614.514, LOT UNKNOWN, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817002 3.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM ORTHOSIS,PEDICLE SPINAL FIXATION NKG SYNTHES MONUMENT 9932235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention