BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3800743 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11304
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. DIFFICULTIES ENCOUNTERED REMOVING LOCKED PLATES. S RAJA, AM IMBULDENIYA, S GARG, G GROOM. ANN R COLL SURG ENGL 2012; 94: 502¿505. THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. A RETROSPECTIVE ANALYSIS WAS PERFORMED OF PATIENTS ENROLLED PROSPECTIVELY INTO A DATABASE. INCLUDED IN THE STUDY WERE 36 CONSECUTIVE ADULT PATIENTS WHO EACH UNDERWENT THE PROCEDURE OF LOCKED PLATE REMOVAL IN A SINGLE INNER CITY LEVEL 1 TRAUMA CENTRE. DATA COLLECTED INCLUDED PRIMARY INDICATION FOR FIXATION, INDICATION FOR IMPLANT REMOVAL, TIME OF THE IMPLANT IN SITU, GRADE OF OPERATING SURGEON AND DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE. IMPLANT REMOVAL WAS ASSOCIATED WITH A COMPLICATION RATE OF 47%. THE MAJOR PROBLEMS ENCOUNTERED WERE DIFFICULTY IN REMOVING THE LOCKED SCREWS AND THE IMPLANT ITSELF. A TOTAL OF TEN COLD WELDED SCREWS WERE FOUND IN EIGHT CASES. REMOVAL WAS FACILITATED BY HIGH SPEED METAL CUTTING BURRS AND SCREW REMOVAL SETS IN ALL BUT ONE CASE, WHERE A DECISION WAS MADE TO LEAVE THE PLATE IN SITU. OVERALL, 36 LOCKED PLATES WERE LISTED FOR REMOVAL FROM 36 CONSECUTIVE PATIENTS. THERE WERE 17 MALE AND 19 FEMALE PATIENTS WITH AN AVERAGE AGE OF 48.4 YEARS (RANGE: 23¿90 YEARS). THE IMPLANTS WERE REMOVED BETWEEN 5 AND 588 DAYS AFTER INSERTION. THE MEAN TIME THAT THE METAL HAD BEEN IN SITU WAS 507.8 DAYS. THE MOST COMMON INDICATION FOR IMPLANT REMOVAL WAS A PAINFUL OR PALPABLE IMPLANT IN 17 PATIENTS, FOLLOWED BY FRACTURE NON-UNION IN 9. IMPLANT FAILURE AND A VASCULAR NECROSIS ACCOUNTED FOR THREE CASES EACH WHILE TWO LOCKED PLATES WERE REMOVED IN RESPONSE TO PATIENT DEMAND. A FURTHER TWO PLATES WERE REMOVED TO HELP FACILITATE ANOTHER PROCEDURE. INFECTION ACCOUNTED FOR A SINGLE CASE. THE MOST FREQUENT PROBLEM ENCOUNTERED WAS COLD WELDING AND STRIPPING OF SCREWS. TEN SCREWS IN EIGHT PATIENTS WERE FOUND TO BE COLD WELDED TO THE PLATE. THEY COULD NOT BE REMOVED FROM THE PLATE AND IN ONE CASE THE PLATE HAD TO BE REMOVED WITH THE SCREW STILL COLD WELDED TO IT. ONE SCREW HEAD WAS FOUND TO BE STRIPPED. SIX PLATES (1 DISTAL FEMORAL LISS, 2 DISTAL TIBIAL LISS, 1 PROXIMAL TIBIAL LISS, 1 FEMORAL LCP AND 1 PHILOS) WERE FOUND BROKEN, ALONG WITH TWO BROKEN SCREWS FROM A SEPARATE DISTAL FEMORAL LISS PLATE. THREE PATIENTS, WHOSE INDICATIONS FOR REMOVAL WERE NON-UNION, HAD FURTHER TREATMENT BY REFIXATION AND BONE GRAFTING. THIS REPORT IS FOR UNKNOWN LISS PLATE FOR INFECTION (1 PATIENT). THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278364 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention