BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE? IMPLANT - LARGE

    MDR report key: 14044865 · Received April 7, 2022

    Report

    Report Number
    0002936485-2022-00170
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    October 4, 2021
    Report Date
    July 19, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    QPQ
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: INSPACE SPACER PUNCTURE. PROBABLE ROOT CAUSE: DESIGN: INADEQUATE SPACER/PLUG/SLEEVE DESIGN, INADEQUATE RAW MATERIAL SPECIFICATION. PROCESS: SPACER OR PLUG NOT MANUFACTURED TO SPECIFICATION, INCORRECT MATERIAL USED DURING MANUFACTURE. APPLICATION: IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION, INCORRECT SPACER SIZE SELECTION, SPACER CONTACT WITH OTHER IMPLANTS, USER UNDERINFLATED OR OVERINFLATED SPACER. PATIENT NONCOMPLIANT WITH POST-OP REHABILITATION SCHEDULE OR EXPOSED TO TOO INTENSIVE PT , INFLAMMATORY REACTION , USE OF MORE THAN ONE SPACER WITHIN JOINT. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. H3 OTHER TEXT : 81.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: INSPACE SPACER PUNCTURE, WHICH ASSOCIATE WITH THE HAZARD OF VOLUME REDUCTION POST-OPERATIVE. PROBABLE ROOT CAUSE: DESIGN: INADEQUATE SPACER/PLUG/SLEEVE DESIGN. INADEQUATE RAW MATERIAL SPECIFICATION. PROCESS: SPACER OR PLUG NOT MANUFACTURED TO SPECIFICATION. INCORRECT MATERIAL USED DURING MANUFACTURE. APPLICATION: IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION. INCORRECT SPACER SIZE SELECTION. SPACER CONTACT WITH OTHER IMPLANTS. USER UNDERINFLATED OR OVERINFLATED SPACER. PATIENT NONCOMPLIANT WITH POST-OP REHABILITATION SCHEDULE OR EXPOSED TO TOO INTENSIVE. PT: INFLAMMATORY REACTION. USE OF MORE THAN ONE SPACER WITHIN JOINT. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPACER PUNCTURED AND DISPLACED RESULTING IN SYNOVITIS AND THE NEED FOR A REVISION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPACER PUNCTURED AND DISPLACED RESULTING IN SYNOVITIS AND THE NEED FOR A REVISION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPACER WAS PUNCTURED AND CAUSED INCREASED SHOULDER PAIN. IT WAS RESULTING IN REVISION SURGERY THAT ALSO DETECTED SYNOVITIS IN THE IMPLANTATION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130697 INSPACE? IMPLANT - LARGE SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER ENDOSCOPY-SAN JOSE 230919-01

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Male Other