BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: 7.3 MM CANNULATED

    MDR report key: 18068861 · Received November 3, 2023

    Report

    Report Number
    8030965-2023-13915
    Event Type
    Injury
    Date Received
    November 3, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN 7.3-MM CANNULATED SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: DEPARTMENT OF TRAUMA AND RECONSTRUCTION SURGERY. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MENDEL T, ET AL. (2023), PERIOPERATIVE OUTCOME OF MINIMALLY INVASIVE STABILISATION OF BILATERAL FRAGILITY FRACTURES OF THE SACRUM: A COMPARATIVE STUDY OF BISEGMENTAL TRANSSACRAL STABILISATION VERSUS SPINOPELVIC FIXATION, EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY (2023) 49:1001¿1010, HTTPS://DOI.ORG/10.1007/S00068-022-02123-6 (GERMANY). THE AIM OF THIS STUDY WAS TO COMPARE THE PERIOPERATIVE OUTCOME OF THE BISEGMENTAL TRANSSACRAL STABILISATION (BTS) AND SPINOPELVIC FIXATION (SP) AS 2 SPECIFIC MINIMALLY INVASIVE FIXATION TECHNIQUES OF THE POSTERIOR PELVIC RING IN BILATERAL FRAGILITY FRACTURES OF THE SACRUM WITH REGARD TO SURGICAL SIDE INFLUENCES ON BLOOD LOSS, COMPLICATIONS, POSTOPERATIVE MOBILITY, AND SOCIAL INTEGRITY. BETWEEN 2015 AND 2018, 74 PATIENTS WITH BILATERAL FRAGILITY FRACTURES OF THE SACRUM AND REMAINED BEDRIDDEN DUE TO PAIN DESPITE CONSERVATIVE TREATMENT WERE INCLUDED IN STUDY. BASED ON INDIVIDUAL FRACTURE MORPHOLOGY AND SACRAL ANATOMY, 49 PATIENTS WERE TREATED WITH SPINOPELVIC FIXATION (SP GROUP) AND 24 PATIENTS WERE TREATED WITH BISEGMENTAL TRANSSACRAL STABILISATION (BTS GROUP). IN THE BTS GROUP, THERE WERE 2 MALES AND 22 FEMALES WITH A MEAN AGE OF 78 ± 12 YEARS AND A MEAN BMI OF 27+/-5 KG/M2. IN THE SP GROUP, THERE WERE 6 MALES AND 43 FEMALES WITH A MEAN AGE OF 80 +/-8 YEARS AND A MEAN BMI OF 27+/-5 YEARS. FOR THE PATIENTS WHO UNDERWENT SPINOPELVIC FIXATION, EITHER UNKNOWN SYNTHES 6.0-MM SACRAL BARS WITH LOCK NUTS OR UNKNOWN SYNTHES 7.3-MM CANNULATED SCREWS WERE USED. FOR THE PATIENTS WHO UNDERWENT BISEGMENTAL TRANSSACRAL STABILISATION, SPINOPELVIC FIXATION WAS PERFORMED FROM THE 5TH LUMBAR VERTEBRA TO BOTH ILIAC WINGS THEN THE UNKNOWN DEPUY SPINE VIPER 2 INTERNAL FIXATOR SYSTEM WAS USED. POLYAXIAL SCREWS WERE INSERTED IN L5 USING A PERCUTANEOUS TECHNIQUE VIA STAB INCISIONS. AT THE ILIUM, POLYAXIAL SCREWS WITH A DIAMETER OF 9 OR 10 MM AND A LENGTH OF AT LEAST 80 MM WERE INSERTED VIA 3-CM INCISIONS AT THE LEVEL OF THE POSTERIOR SUPERIOR ILIAC SPINE. THE ILIAC SCREWS WERE CONNECTED HORIZONTALLY BY A 5.5-MM ROD INSERTED SUBFASCIALLY OVER THE GUIDE SLEEVES. THE CONNECTION TO L5 WAS THEN MADE BY INSERTING LATERAL CONNECTORS UNKNOWN DEPUY EXPEDIUM 5.5 SPINE SYSTEM. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT WHO HAD SURGERY UNDER THERAPEUTIC ANTICOAGULATION DEVELOPED A WOUND HAEMATOMA REQUIRING REVISION SURGERY. 1 PATIENT DIED OF AN ACUTE PULMONARY EMBOLISM DURING THE INPATIENT STAY. 1 PATIENT DIED BECAUSE OF AN ACUTE GASTRIC PERFORATION, HAVING PREVIOUSLY KNOWINGLY REFUSED EMERGENCY SURGERY. 1 PATIENT DIED OF AN ACUTE THROMBOEMBOLIC EVENT. THIS REPORT IS FOR UNKNOWN SYNTHES 7.3-MM CANNULATED SCREWS. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154565 UNK - SCREWS: 7.3 MM CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention