BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    MDR report key: 5064041 · Received September 9, 2015

    Report

    Report Number
    1719045-2015-10581
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    August 27, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    PK031276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 510K SUBMISSION NUMBERS: K030866, K000536. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: LOT NUMBER PROVIDED INDICATES THE PART WAS SOLD IN 1998, AND MANUFACTURING LOT RECORDS WERE NOT FOUND IN JDE. A SEARCH SHOWS THE DEVICE WAS MANUFACTURED IN (B)(4) FACILITY IN 1997. DEVICE HISTORY AGAIN REDIRECTED TO (B)(4) FOR DHR. DHR WILL BE COMPLETED BY CHU ENGINEER DUE TO AGE OF DEVICE. DHR REVIEW FOR PART#450.237 LOT#A4GJ038. RELEASE TO WAREHOUSE DATE: AUGUST 22, 1997 BY (B)(4), NO NCRS 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. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF A CERVICAL SPINE LOCKING PLATE (CSLP), SIX EXPANSION HEAD SCREWS AND SIX LOCKING SCREWS DUE TO PLATE BREAKAGE. THE PLATE WAS AT LEVELS C5, C6, AND C7. THE RETURNED IMPLANTS WERE EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE CSLP PLATE (450.237 LOT A4GJ038) WAS FOUND TO BE BROKEN IN TWO WITH THE FRACTURE SITE LOCATED AT THE CENTER TOP HOLD LOCATION. A DEFINITIVE ROOT CAUSE WAS UNABLE DETERMINED WITH THE PROVIDED INFORMATION. ADDITIONALLY SIX EXPANSION HEAD AND SIX LOCKING SCREWS WERE RETURNED IN A CONDITION CONSISTENT WITH IMPLANTATION AND EXPLANATION (I.E. NICKS/SCRATCHES/WORN ANODIZATION). AS NO ALLEGATIONS ARE MADE AGAINST THESE DEVICES NO FURTHER INVESTIGATION IS NECESSARY. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION, THIS INVESTIGATION SUMMARY WAS APPROVED. 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 A PATIENT UNDERWENT REMOVAL OF A CERVICAL SPINE LOCKING PLATE, SIX (6) UNKNOWN EXPANSION HEAD SCREWS, AND SIX (6) UNKNOWN LOCKING SCREWS DUE TO PLATE BREAKAGE. THE PLATE WAS AT LEVELS C5, C6, AND C7. INITIAL IMPLANT DATE IS UNKNOWN. THERE WAS NO SURGICAL DELAY, OR OTHER PATIENT HARM REPORTED. THE PLATE BROKE AT ONLY ONE SCREW HOLE; IT IS UNKNOWN WHICH SCREW CONTRIBUTED TO THE COMPLAINED EVENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596527 TI CERVICAL SPINE LOCKING PLATE 45MM (37MM) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MONUMENT A4GJ038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention