BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENNOVATE C SET SCREWS STERILE.

    MDR report key: 19872913 · Received July 31, 2024

    Report

    Report Number
    9610612-2024-00222
    Event Type
    Injury
    Date Received
    July 31, 2024
    Report Date
    July 31, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    NKG
    PMA / PMN Number
    K213871
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE INVESTIGATION AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE MENTIONED FAILURE /ERROR PATTERNS. IF THE PRODUCT IS RETURNED IN THE FUTURE, A NEW INVESTIGATION WILL BE PERFORMED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT SQ002TS - ENNOVATE C SET SCREWS STERILE. ACCORDING TO THE COMPLAINT DESCRIPTION, TREATMENT WAS INITIATED 18 MONTHS AGO WITH ENNOVATE CERVICAL SYSTEM IN (B)(6) 2023. THERE HAD BEEN POSTOPERATIVE INSTABILITY OF "HWK" 3/4 FOLLOWING A FUSION CERVICAL 1/2 (2007 EX DOMO). DURING THE SURGERY, THE TRANSARTICULAR SCREWS WERE CHANGED AND THE INSTRUMENTATION WAS EXTENDED TO THE THORACIC SIDE. ACCORDING TO THE X-RAY RESULTS, THE LOCKING NUTS IN BOTH TRANSARTICULAR SCREW HEADS HAVE LOOSENED AND THE ROD HAS DISLOCATED ACCORDINGLY. IN VIEW OF THE PATIENT'S AGE, NO SURGICAL REVISION IS INDICATED. THE PATIENT NOTED THAT THE MYELOPATHY HAD NOT BETTERED ITSELF BUT ALSO DID NOT WORSEN. PAIN MEDICATION IS BEING TAKEN ONLY DUE TO RHEUMATOID DISEASE. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). ASSOCIATED MEDWATCH REPORTS: SQ002TS - 9610612-2024-00221 (INTERNAL AESCULAP AG REF. NO. (B)(4). SQ002TS - SQ002TS - 9610612-2024-00222 (INTERNAL AESCULAP AG REF. NO. (B)(4). INVOLVED COMPONENTS: SQ342TS - ENNOVATE C FAV.ANG.SCREW 4.0X42MM CANUL (INTERNAL AESCULAP AG REF. NO. (B)4). SQ216TS - ENNOVATE C POLYAX.SCREW 4.0X16MM CANUL. (INTERNAL AESCULAP AG REF. NO. (B)(4). SQ004TS - ENNOVATE C STRAIGHT ROD 3.5X150MM (INTERNAL AESCULAP AG REF. NO. (B)(4). SQ004TS - ENNOVATE C STRAIGHT ROD 3.5X150MM (INTERNAL AESCULAP AG REF. NO. (B)(4). SQ166TS - ENNOVATE C POLYAX.SCREW 3.5X16MM SOLID (INTERNAL AESCULAP AG REF. NO. (B)(4). SQ336TS - ENNOVATE C FAV.ANG.SCREW 4.0X36MM CANUL. (INTERNAL AESCULAP AG REF. NO. (B)4). SQ232TS - ENNOVATE C POLYAX.SCREW 4.0X32MM CANUL. (INTERNAL AESCULAP AG REF. NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239895 ENNOVATE C SET SCREWS STERILE. SPINE SURGERY NKG AESCULAP AG SQ002TS 52789488

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention SQ004TS - LOT 52777823| SQ004TS - LOT 52802003| SQ166TS - LOT 52779757| SQ216TS - LOT 52771860| SQ232TS - LOT 52767965| SQ336TS - LOT 52688498| SQ342TS - LOT 52687862