BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CERV SELF-RETAIN SCR

    MDR report key: 2944922 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10020
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K071667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A FIRST INSPECTION ARTICLE REPORT WAS FILLED OUT WITH NO DEVIATIONS. THE DIMENSIONS OF THE SCREWS IN QUESTION WERE MEASURED AND FOUND ACCORDING TO THE SPECIFICATION. MEASUREMENT AND A FUNCTION TEST OF THE PLATE HOLES WAS IMPOSSIBLE AS ALL CLIPS ARE DEFORMED. THEREFORE, SYNTHES WAS NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE, ALSO IT IS UNCLEAR WHY 7 SCREWS WERE USED FOR A 4-HOLE PLATE. BASED ON THE PROVIDED INFORMATION, THE SYNTHES CAN ONLY ASSUME THAT A COMPLICATION DURING THE PROCEDURE CAUSED THE COMPLAINED MALFUNCTION.

    Description of Event or Problem · 1

    DURING THE ACDF PROCEDURE AT LEVELS C5-C6, THE SURGEON IMPLANTED THE VECTRA PLATE (04.613.012) WITH 7 SCREWS. THE SURGEON DID NOT LIKE HOW THE LAST SCREW WENT IN AND THOUGHT THE ANGLE/PATH OF THE SCREW WAS INCORRECT. THE SURGEON DECIDED TO REMOVE THE SCREWS USING THE EXTRACTION SCREWDRIVER (352.311) THAT HAS A SPECIAL OUTER SLEEVE TO PROTECT THE PLATE FROM DAMAGE. THE SURGEON OVERTIGHTENED THE SLEEVE, AND THAT CAUSED THE ELGILOY CLIP ON THE PLATE TO COME OUT. THE SURGEON REMOVED ALL IMPLANTS (PLATE AND 7 SCREWS), BUT DID NOT HAVE ANOTHER PLATE OF THIS TYPE. TRIED TO USE 14MM PLATE, BUT IT WAS TOO BIG. THE SURGEON USED THE COMPETITOR PLATE AND SCREWS (MEDTRONIC) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS INCIDENT PROLONGED THE SURGERY BY 20-30 MINUTES. THIS COMPLAINT IS ON THE 7TH SCREW (04.613.864) AND THIS COMPLAINT IS 8 OF 9 FOR THE SAME REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44748 4.5MM TI CERV SELF-RETAIN SCR KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG# 04.613.614, LOT #UNK| CATALOG# 04.613.864, LOT# UNK| SCREWS| VECTRA PLATE| CATALOG# 04.613.012, LOT# 1461882| 4.0MM TI CERV SELF-RETAIN SCR| 4.0MM TI CERV SELF-RETAIN SCR| CATALOG# 04.613.814, LOT# UNK| 4.5MM TI CERV SELF-RETAIN SCR| TI VECTRA (TM) PLATE| EXTRACTION SCREWDRIVER