BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSALOK ANCHOR WITH ORTHOCORD

    MDR report key: 6379245 · Received March 5, 2017

    Report

    Report Number
    1221934-2017-10086
    Event Type
    Injury
    Date Received
    March 5, 2017
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K063478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE SURGERY HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. A STERILE LOAD CHECK WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED. IT CANNOT BE DETERMINED THAT THE DEVICES WERE THE ROOT CAUSE OF THE PATIENT'S INFECTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10087, 1221934-2017-10088, 1221934-2017-10089, 1221934-2017-10090.

    Description of Event or Problem · 1

    (B)(4) INVESTIGATION CASE: IT WAS INFORMED BY (B)(6) WHO GOT A FORMAL LETTER FROM (B)(6) FOR INVESTIGATION ON A SUSPECTED POST-OP INFECTION CASE. A UNKNOWN SURGERY WAS PERFORMED IN (B)(6). EXACT SURGERY DATE IS ALSO UNKNOWN. THE FOLLOWING MITEK SCREWS HAVE BEEN IMPLANTED. CODE: 210808, LOT:3828999 CODE: 222205, LOT:3858654 POSTOPERATIVE INFECTION WAS REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. SALES REP IS STILL VERIFYING THE DETAILS. (B)(4) IS PLANNING TO TAKE A SAMPLING TESTING ON THE RELATED DEVICES. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 2-7-17: PATIENT HAS (3) 210808 LOT NUMBER 3828999 STILL IMPLANTED INSTEAD OF (1); PATIENT HAS (2) 222205 LOT NUMBER 3858654 STILL IMPLANTED INSTEAD OF (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161834 VERSALOK ANCHOR WITH ORTHOCORD MITEK ANCHOR IMPLANTS HWC DEPUY MITEK 3828999

    Patients

    Seq Age Sex Outcome Treatment
    1 Other