BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG

    MDR report key: 3971284 · Received July 31, 2014

    Report

    Report Number
    3009450884-2014-10045
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK091644
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE PLATE IS BADLY BENT AND AN INVESTIGATION OF SUCH DAMAGE IS INDICATION OF EXCESS FORCE OR TORQUE APPLIED TO THE PLATE. THE DEVICE REPORT STATES THE PLATE WAS IMPLANTED IN (B)(6) 2014 BUT WAS REMOVED IN (B)(6) 2014. THIS WOULD BE CONSIDERED QUITE A SHORT PERIOD OF TIME, AS BONE FUSION MAY NOT HAVE FULLY OCCURRED. IN ADDITION THE PATIENT WAS UNDERGOING PHYSICAL THERAPY, WHICH MAY HAVE PUT EXTRA STRAIN ON THE PLATE AND NO INDICATION OF WHAT THIS THERAPY INVOLVED. THE DEVICE HISTORY RECORD WAS INVESTIGATED FOR THE LOT 8629277 WHICH WAS PRODUCED IN (B)(4) 2013. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT'S HEIGHT -160 CENTIMETERS; PATIENT'S BMI- (B)(6). DATE OF EVENT IS UNKNOWN. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO NCRS GENERATED DURING PRODUCTION. 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: EXACT DATE UNKNOWN BUT REPORTED AS A WEEK AFTER (B)(4) 2014. 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 THE PATIENT HAD A MAL-UNION AND HAD AN OSTEOTOMY PROCEDURE OF THE EXTRA ARTICULAR LEFT WRIST WITH AN ANTERIOR PLATE. AFTER ONE MONTH, THE ANTEROPOSTERIOR PLATE SUDDENLY BEGAN BOWING; THE PATIENT WAS UNDER PHYSICAL THERAPY. IT WAS REPORTED THAT THE PATIENT NEEDED MEDICAL/SURGICAL INTERVENTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446866 TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 8629277

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention