BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASFORA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 9293580 · Received November 7, 2019

    Report

    Report Number
    2135141-2019-00005
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 7, 2019
    Manufacturer
    MEDICAL DESIGNS, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K143688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DESIGNS REVIEWED THE INFORMATION PROVIDED BY THE SURGEON ALONG WITH THE DEVICE HISTORY RECORDS (DHR) FOR LOT# 3272 AND 3234. THE DHR FOR THESE LOTS DID HAVE NONCONFORMANCES ISSUED. HOWEVER, THE NONCONFORMANCES WERE REVIEWED BY MEDICAL DESIGNS AND NOT DEEMED RELEVANT TO THE SCREWS BACKING OUT. THEREFORE, BASED ON THE INFORMATION RECEIVED, THERE IS NOT ENOUGH INFORMATION FOR MEDICAL DESIGNS TO DETERMINE THE DEFINITIVE CAUSE FOR THE SCREWS BACKING OUT. MEDICAL DESIGNS WILL EVALUATE THE EXPLANTED HARDWARE UPON RECEIPT AND CONTINUE THE INVESTIGATION OF THIS INCIDENT. UPON COMPLETION OF THE INVESTIGATION OF THE EXPLANTED HARDWARE, AN ADDENDUM WILL BE ADDED TO THE COMPLAINT AND A SUPPLEMENTAL REPORT MAY BE SUBMITTED TO THE FDA. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO, AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF MEDICAL DESIGNS, LLC, THAT THE PRODUCT, WHICH IS THE SUBJECT OF THIS REPORT, IN ANY WAY MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT INITIALLY HAD A 3-LEVEL CERVICAL FUSION ON (B)(6) 2017, WITH THE ASFORA ANTERIOR CERVICAL PLATE (AACP) SYSTEM. PATIENT REPORTEDLY FELL IN (B)(6) 2017 AND X-RAYS INDICATED THAT THE HARDWARE WAS INTACT FOLLOWING THE FALL. PATIENT RECENTLY REPORTED OF RECURRENT PAIN AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019 FOR REMOVAL OF THE AACP HARDWARE. THE SURGEON PERFORMING THE REMOVAL INDICATED THAT THE TWO MOST SUPERIOR AACP SCREWS HAD BACKED OUT COMPLETELY AND APPEARED TO BE LOOSE WITHIN THE PREVERTEBRAL SPACE. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS WITH THE REMOVAL. THE SURGEON REMOVED ONE (1) PLATE (11-1106-FD3-60, LOT# 3272) AND EIGHT (8) 16MM VARIABLE ANGLE LOCKING SCREWS (11-1106-FD7-16, LOT# 3234). MEDICAL DESIGNS REVIEWED THE INFORMATION PROVIDED BY THE SURGEON, ALONG WITH THE DEVICE HISTORY RECORD (DHR) FOR LOT# 3272 AND 3234. THE DHR FOR THESE LOTS DID HAVE NONCONFORMANCES ISSUED. HOWEVER, THE NONCONFORMANCES WERE REVIEWED BY MEDICAL DESIGNS AND DEEMED NOT RELEVANT TO THE SCREWS BACKING OUT. MEDICAL DESIGNS HAS REQUESTED THE HARDWARE BE RETURNED FROM THE HOSPITAL. UPON RECEIPT OF THE HARDWARE, MEDICAL DESIGNS WILL PERFORM A THOROUGH INVESTIGATION. IF FURTHER INFORMATION IS OBTAINED THROUGH THE INVESTIGATION THAT INDICATES A PRODUCT MALFUNCTION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088458 ASFORA ANTERIOR CERVICAL PLATE SYSTEM CERVICAL FUSION SYSTEM KWQ MEDICAL DESIGNS, LLC 11-1106-FD3-60 AND 11-1106-FD7-16 3272 AND 3234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention