BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 1565694 · Received December 23, 2009

    Report

    Report Number
    3005039508-2009-00022
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE SCREW HEAD WAS SCRATCHED & DEFORMED WHERE THE PLIERS WERE USED TO REMOVE THE IMPLANT. THE DISTAL 2/3 THREADS HAD THE TIPS OF THE THREAD CRESTS FLATTENED OUT. IT IS HIGHLY UNLIKELY THAT EVEN HARD BONE WOULD CAUSE THIS PLASTIC DEFORMATION OF THE THREAD CRESTS. WE HAVE SEEN THIS TYPE OF UNIFORM THREAD DAMAGE WHEN THE SCREW CONTACTS ANOTHER OBJECT (K-WIRE, OTHER SCREW, RETRACTOR,...) WHILE BEING DRIVEN INTO THE BONE. CONCLUSION - IT WAS REPORTED THAT THE SURGEON DID NOT FOLLOW THE SURGICAL TECHNIQUE BY PRE-DRILLING THE BONE BEFORE IMPLANTING THE SCREW, THE FAILURE IS CONSISTENT WITH THIS CONDITION.

    Description of Event or Problem · 1

    WHILE PERFORMING A PROCEDURE IN EXTREMELY HARD BONE, THE SURGEON WAS IMPLANTING A SCREW PRIOR TO IMPLANTING A MTP PLATE, WHEN THE SCREW STOPPED ADVANCING. THE SURGEON DID NOT PREDRILL FOR THE SCREW PER THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGNS, INC. HCS-010-38-32

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention