BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRALOK 5.0MM O-C NO NEEDLES

    MDR report key: 9700834 · Received February 12, 2020

    Report

    Report Number
    1221934-2020-00532
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    June 25, 2010
    Report Date
    February 3, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    PMA / PMN Number
    K041069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> PC-(B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE RIGHT SHOULDER, A SPIRALOCK-ORTHOCORD IMPLANTED AND IT WAS NOTICED THAT THE TENDON WAS THICKENED AND WITH IMPAIRED SIGNAL INTENSITY WITHOUT APPRECIABLE CLEAR SIGNS OF INTERRUPTION.THE COMPLAINT DEVICE IS NOT BEING RETURNED DUE TO IT IS STILL IMPLANTED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 3200407, AND NO NON-CONFORMANCES WERE IDENTIFIED.  AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI:UNAVAILABLE THE UDI IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS SUBJECTED TO A SURGICAL PROCEDURE AT THE RIGHT SHOULDER WHERE SHE RECEIVED A SPIRALOCK-ORTHOCORD IMPLANT. DATE: (B)(6) 2008. THE PATIENT WAS SUBJECTED TO A MR (B)(6) 2010 WHERE IT WAS NOTICED THAT THE TENDON WAS THICKENED AND WITH IMPAIRED SIGNAL INTENSITY WITHOUT APPRECIABLE CLEAR SIGNS OF INTERRUPTION. FOLLOWING A DIAGNOSIS OF "RIGHT SHOULDER CONFLICT SYNDROME WITH SUTURE" THE PATIENT WAS SUBJECTED TO A REVISION SURGERY AT (B)(6) ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163106 SPIRALOK 5.0MM O-C NO NEEDLES SOFT-TISSUE ANCHOR, BIODEGRADABLE HWC DEPUY MITEK LLC US 3200407

    Patients

    Seq Age Sex Outcome Treatment
    1