BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC LCP HIP PLATE 2.7MM/130°/2 HOLES-STERILE

    MDR report key: 8536404 · Received April 22, 2019

    Report

    Report Number
    8030965-2019-63009
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    March 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819431638
    PMA / PMN Number
    K112085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: X-RAY REVIEW: NARRATIVE (SCREW WENT THROUGH THE HOLE OF THE PLATE) COULD BE VERIFIED FROM PROVIDED X-RAYS. DEVICE MANUFACTURE DATE: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 02.108.303S. LOT: 3823509. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 20 JUNE 2011. EXPIRY DATE: 01. JUNE 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE EVALUATED BY MFR: A PRODUCT INVESTIGATION WAS CONDUCTED. ONE LCP PLATE. HIP PLATE AND THREE LOCKING SCREWS WERE RETURNED FOR INVESTIGATION. CUSTOMER CONFIRMED THAT THE LONGEST LOCKING SCREW WENT THROUGH THE PLATE HOLE. IMPLANTS WERE FORWARDED TO THE MANUFACTURING SITE AND WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. ABSTRACT FROM MANUF. EVALUATION: THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS LCP PLATE. HIP PLATE WAS MANUFACTURED IN JUNE 2011 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. NO VISUAL DAMAGE WAS FOUND ON THE LCP PAED. HIP PLATE. THE PLATE SHOWS NORMAL SIGNS OF WEAR SUCH AS STRAINS AND SCRATCHES ON THE SURFACE. THE DIMENSIONAL RE-INSPECTION, THE RAW MATERIAL CERTIFICATE REVIEW AND THE DOCUMENT/SPECIFICATION REVIEW DIDN¿T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INITIALLY A PATIENT WAS IMPLANTED WITH PEDIATRIC LOCKING COMPRESSION PLATE (LCP) HIP PLATE SYSTEM ON (B)(6) 2019. AN X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THAT ONE (1) UNKNOWN LOCKING SCREW (PROXIMAL) WENT THROUGH THE HOLE OF THE PEDIATRIC LCP HIP PLATE. AN ADDITIONAL HOSPITALIZATION OF FIVE (5) DAYS AND RE-OPERATION WAS REQUIRED. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: CORTEX SCREW (PART 202.890, LOT # UNKNOWN, QUANTITY 1) 2.7MM LOCKING SCREW 24MM (PART # 202.212, LOT # UNKNOWN, QUANTITY 1); 2.7MM LOCKING SCREW 12MM (PART # 202.224, LOT # UNKNOWN, QUANTITY 1); 2.7MM LOCKING SCREW 14MM (PART # 202.214, LOT # UNKNOWN, QUANTITY 1); THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329016 PEDIATRIC LCP HIP PLATE 2.7MM/130°/2 HOLES-STERILE PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 3823509 07611819431638

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention SEE EVENT DESCRIPTION