BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5821820 · Received July 26, 2016

    Report

    Report Number
    2520274-2016-13551
    Event Type
    Injury
    Date Received
    July 26, 2016
    Report Date
    July 12, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SIT, Y. AND LUI, T. (2014). CORRECTIVE OSTEOTOMY IN FEMORAL NON-UNION IN DRUG-INDUCED HYPOPHOSPHATAEMIC OSTEOMALACIA. BMJ CASE REP, DOI:10.1136/BCR-2013-201269. THIS REPORT IS FOR 7.3MM SHORT THREAD TITANIUM CANNULATED SCREWS / UNKNOWN QUANTITY / UNKNOWN LOT. (OTHER NUMBER): UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, SIT, Y. AND LUI, T. (2014). CORRECTIVE OSTEOTOMY IN FEMORAL NON-UNION IN DRUG-INDUCED HYPOPHOSPHATAEMIC OSTEOMALACIA. BMJ CASE REP, DOI:10.1136/BCR-2013-201269. THE AUTHORS REPORT A CASE STUDY OF FRACTURE MANAGEMENT USING SYNTHES SCREWS IN THE PRESENCE OF HYPOPHOSPHATAEMIA OSTEOMALACIA. A (B)(6) MALE PRESENTED WITH A DISPLACED LEFT FEMORAL NECK FRACTURE IN (B)(6) 2011 AND CONCURRENT, CHRONIC (B)(6) TREATED WITH ADEFOVIR. BLOOD TEST BEFORE INJURY SHOWED ELEVATED ALKALINE PHOSPHATE AND LOW SERUM PHOSPHATE LEVEL. THE LEFT FEMORAL FRACTURE WAS TREATED WITH CLOSED REDUCTION AND SCREW FIXATION USING SYNTHES 7.3MM SHORT THREADED TITANIUM SCREWS. SUBSEQUENTLY, RADIOGRAPHS SHOWED NON-UNION AND BACK OUT OF THE SCREWS IN THE PRESENCE OF PERSISTENT LEFT HIP PAIN. AT A LATER TIME, THE PATIENT PRESENTED WITH RIGHT HIP PAIN; RADIOGRAPHS SHOWED DISPLACED FRACTURE OF THE RIGHT FEMORAL NECK. THE RIGHT FEMORAL FRACTURE WAS ALSO TREATED WITH CLOSED REDUCTION AND INTERNAL SCREW FIXATION USING SYNTHES 7.3MM SHORT THREAD TITANIUM CANNULATED SCREWS. SUBSEQUENT RADIOGRAPHS SHOWED BILATERAL FEMORAL NECK NON-UNION WITH BACK-OUT OF THE SCREWS IN THE PRESENCE OF BONE PAIN AND FATIGUE. IN (B)(6) 2011, ADEFOVIR WAS SWITCHED TO TENOFOVIR. THE PATIENT WAS DIAGNOSED WITH HEPATOCELLULAR CARCINOMA AND DECOMPENSATING CIRRHOSIS IN (B)(6) 2012; MULTIPLE INSUFFICIENCY FRACTURES WERE CONSISTENT WITH OSTEOMALACIA. THE PATIENT EXPERIENCED A NEW SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR. A CORRECTIVE OSTEOTOMY OF THE LEFT PROXIMAL FEMUR WAS UNDERTAKEN FOR NON-UNION WITH REMOVAL OF THE HIP SCREWS; A VALGUS CLOSING WEDGE OSTEOTOMY WAS PERFORMED AT THE SUBTROCHANTERIC FRACTURE SITE. CEPHALOMEDULLARY FIXATION WAS PERFORMED WITH COMPETITOR NAIL. THE AUTHORS INSTITUTED PHOSPHATE SUPPLEMENTS A DAY AFTER THE PATIENT'S LAST OPERATION. THEY REPORTED THAT WITHHOLDING OF THIS SUPPLEMENT WAS ONE REASON THAT LEAD TO NON-UNION. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 7.3MM SHORT THREAD TITANIUM CANNULATED SCREWS AND REFERS TO SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476284 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention