BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAMMERLOCK

    MDR report key: 2827140 · Received September 20, 2012

    Report

    Report Number
    1649263-2012-00001
    Event Type
    Other
    Date Received
    September 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BIOMEDICAL ENT., INC.
    Product Code
    HTY
    PMA / PMN Number
    K091951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BME RECOMMENDS A CONSERVATIVE POST-OP PROTOCOL BE USED IN CONJUNCTION WITH THE HAMMERLOCK IMPLANT. THIS ENTAILS IMMOBILIZATION DURING THE BONE HEALING PERIOD OF APPROX SIX WEEKS FOLLOWED BY VERIFICATION OF FUSION AND SUBSEQUENT ADD¿L IMMOBILIZATION AT THE SURGEONS DISCRETION. BME CAUTIONS AGAINST A MORE AGGRESSIVE APPROACH EVEN IF EARLY RADIOGRAPHIC FILMS MAY REVEAL WHAT APPEARS TO BE RAPID CONSOLIDATION. IN ADDITION, PATIENT COMPLIANCE IS CRUCIAL TO POSITIVE OUTCOMES. HAMMERLOCK IMPLANTS ARE CONTRAINDICATED IN THE FOLLOWING INSTANCES: PATHOLOGIC CONDITIONS OF BONE, SUCH AS OSTEOPENIA, WHICH WOULD IMPAIR THE ABILITY TO SECURELY FIX THE IMPLANT. FOREIGN BODY SENSITIVITY TO METALS INCLUDING NICKEL. WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE PRIOR TO IMPLANTATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT CONTACTED BME SALES MANAGER WITH A CONCERN THAT THE HAMMER TOE SURGERY ON (B)(6) 2012 DID NOT RESULT IN A PROPER UNION AT THE SURGERY SITE. THE PT ALSO STATED THAT SHE WAS CONCERNED WITH A POSSIBLE REACTION TO THE METAL. ON (B)(6) 2012 ¿ BME RECEIVED A MAUDE EVENT REPORT (B)(4) DATED (B)(4) 2012, STATING THAT THE PT SELF-REPORTED THE ADVERSE EVENT. BME SUBSEQUENTLY REOPENED THE COMPLAINT FILE. ON (B)(4) 2012- SALES MANAGER REPORTS THAT THE PT CALLED ON (B)(6) 2012 AND SAID THAT NO CONTACT HAS BEEN MADE BETWEEN BME AND THE PT. THE PT WAS THEN INFORMED TO CONTACT HER PHYSICIAN CONCERNING THE ISSUE. ON (B)(4) 2012- CALLED AND SPOKE TO DR (B)(6). THE PHYSICIAN STATED THAT THERE WERE NO PRE-EXISTING CONDITIONS THAT CONTRIBUTED TO THE NON-UNION OR THE POSSIBLE METAL SENSITIVITY NOR WAS A METAL SENSITIVITY REPORTED BY THE PT. THE PHYSICIAN STATED THAT THE PT HAD 7 SCREWS AND A PLATE IN THE SAME FOOT, NONE OF WHICH CONTAINED NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMMERLOCK HAMMERLOCK IMPLANT: MEDIUM ANGLED HTY BIOMEDICAL ENT., INC. HLXMA BMEHL11182

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R