BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAK IMPLANT

    MDR report key: 477891 · Received August 10, 2003

    Report

    Report Number
    MW1029275
    Event Type
    Other
    Date Received
    August 10, 2003
    Date of Event
    September 1, 1999
    Report Date
    August 10, 2003
    Manufacturer
    SPINE TECH INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 09/09/03: THE REPORT INDICATES THAT THE PT IS EXPERIENCING PAIN IN THE HIP REGION. PAIN IN THIS AREA OF THE BODY IS NOT CONSISTENT WITH THE TARGET IMPLANT LOCATION OF A BAK IMPLANT PROCEDURE. AS A RESULT, IT IS HIGHLY PROBABLE THAT THE PAIN THE PT IS EXPERIENCING IS RESIDUAL FROM THE PROCEDURE AND NOT A RESULT, DIRECTLY OR INDIRECTLY, OF THE MEDICAL IMPLANTABLE DEVICES THEMSELVES. AS PART OF A BAK SPINAL FUSION IMPLANT SURGERY, AS WELL AS OTHER PROCEDURES TO INCLUDE, BUT NOT LIMITED TO: JOINT ARTHRODESIS; TOTAL JOINT REPLACEMENT; FRACTURE REPAIR; MAXILLFACIAL RECONSTRUCTION; AND TUMOR REMOVAL, A SURGEON MAY ELECT TO HARVEST AUTOGENOUS BONE GRAFT MATERIAL FROM A DONOR LOCATION WITHIN THE PT. THIS PROCEDURE IS FREQUENTLY PERFORMED ON THE ILIAC CREST OF THE HIP. THERE ARE NUMEROUS DEVICES AVAILABLE ON THE MARKET THAT ARE INTENDED TO CUT AND COLLECT FINELY MORSELIZED AUTOGENOUS BONE GRAFT FOR ANY SURGICAL PROCEDURE REQUIRING BONE GRAFT TO FACILITATE FUSION AND/OR FILL BONE DEFECTS. PRECAUTIONS RELATED TO THE USE OF THESE DEVICES OFTEN SPECIFY THAT THE PT MUST BE WARNED OF SURGICAL RISKS AND ADVISED THAT NON-COMPLIANCE WITH POSTOPERATIVE INSTRUCTIONS COULD LEAD TO PROLONGED DONOR SITE MORBIDITY, INCLUDING PROLONGED PAIN, INFECTION AND/OR EXCESSIVE DRAINAGE, WHICH MAY REQUIRE ADD'L SURGERY. ADDITIONALLY, AS A STANDARD PRECAUTION, THE PT MUST BE MADE AWARE OF POSSIBLE ADVERSE EFFECTS OF BONE GRAFT HARVESTING, INCLUDING DONOR SITE BONE FRACTURE, NEUROVASCULAR DAMAGE, AND/OR INFECTION. ISSUES RELATED TO PT RECOVERY ARE GENERALLY MANAGED BY THE PT'S PRIMARY CARE PHYSICIAN AND/OR THE OPERATING SURGEON DURING THE POST-OPERATIVE CARE PERIOD. FOLLOWING THE REVIEW OF THIS REPORT, CENTERPULSE SPINE-TECH HAS DETERMINED THAT THE SYMPTOMS EXPERIENCED BY THIS PT ARE NOT INDICATIVE OF A DEVICE FAILURE. THIS REPORT WILL BE CLOSED WITHOUT ADD'L INVESTIGATION UNTIL FURTHER EVIDENCE IS PRESENTED TO WARRANT REOPENING OF THE FILE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 02/25/04: THIS LETTER IS IN RESPONSE TO A LETTER ZIMMER SPINE RECEIVED ON JANUARY 30, 2004 REGARDING MW1029275. AFTER FURTHER INVESTIGATION ZIMMER HAS DETERMINED THAT THIS EVENT WAS PREVIOUSLY REPORTED TO THEM AND RESPONDED TO DATED SEPTEMBER 9, 2003.

    Description of Event or Problem · 1

    PT HAVING SEVERE HIP PAIN THEY BELIEVE FROM AN OPERATION THAT THEY HAD IN 1999. THEY HAD BAK IMPLANTS AS LEVELS L-4 AND L-5/S-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK IMPLANT SPINE DEVICE MAX SPINE TECH INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other