BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXP TI UNI SCW 5MMX40MM

    MDR report key: 10510010 · Received September 9, 2020

    Report

    Report Number
    1526439-2020-01629
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034081229
    PMA / PMN Number
    K160904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: KWP; MNH; MNI; OSH. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: COMPLAINT SUMMARY: IT WAS REPORTED ON AN UNKNOWN DATE, THE EXPEDIUM 5.5 UNIPLANAR SCREW FAILED TO ACCEPT SET SCREW WHEN TRYING TO IMPLANT ROD. IT APPEARS THE SCREW HEAD MAY HAVE SPLAYED AND THE TULIP THREADS ARE DAMAGED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THE IMPLANT(S) WAS NOT RETURNED AND INSTEAD THE INVESTIGATION WILL BE DONE BASED ON THE SUPPLIED IMAGE(S). THE IMAGE(S) WAS REVIEWED AND THE COMPLAINT CONDITION FOR DAMAGED THREADS COULD BE CONFIRMED AS THE IMAGE PROVIDED SHOWS DAMAGED THREADS. AS THE IMPLANT(S) WAS NOT RETURNED AN AS RECEIVED CONDITION, DIMENSIONAL INSPECTION, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR EXP TI UNI SCW 5MMX40MM WAS CONDUCTED IDENTIFYING THAT LOT NUMBER RL264069 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT WAS RELEASED ON NOV 28, 2017 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY REVIEW: THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXPEDIUM 5.5 UNIPLANAR SCREW FAILED TO ACCEPT SET SCREW WHEN TRYING TO IMPLANT ROD. IT APPEARS THE SCREW HEAD MAY HAVE SPLAYED AND THE TULIP THREADS ARE DAMAGED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN INSERTION INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP TI UNI SCW 5MMX40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975236 EXP TI UNI SCW 5MMX40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 179788540 RL264069 10705034081229

    Patients

    Seq Age Sex Outcome Treatment
    1