BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 EXP VERSE UNITIZED SET SCR

    MDR report key: 13090666 · Received December 27, 2021

    Report

    Report Number
    1526439-2021-02654
    Event Type
    Injury
    Date Received
    December 27, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKB
    UDI-DI
    10705034466149
    PMA / PMN Number
    K142185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: KWP; KWQ; MNH; MNI; OSH. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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.

    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. H10 ADDITIONAL NARRATIVE: H6 - CODES UPDATED TO IMDRF CODES. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION BASED ON THE IMAGES UPLOADED ON THE PC TITLED "PHOTOS_PC-001029148_NIHONKAI GENERAL HOSPITAL(SP202100363)". VISUAL ANALYSIS OF THE UPLOADED IMAGES REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE 5.5 EXP VERSE UNITIZED SET SCR. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE 5.5 EXP VERSE UNITIZED SET SCR AS THE DEVICE WAS NOT RETURNED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE 5.5 EXP VERSE UNITIZED SET SCR WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW - THERE IS NO KNOWN LOT NUMBER, THEREFORE A MRE CANNOT BE COMPLETED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT THE PRIMARY TLIF (L5/6) PROCEDURE FOR TREATING BOTH LUMBAR INTERVERTEBRAL FORAMEN STENOSIS AND LUMBAR DISC HERNIA ON (B)(6) 2021. ON (B)(6), THE PATIENT UNDERWENT A HEMATOMA REMOVAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS REPORT IS 9 OF 9 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986190 5.5 EXP VERSE UNITIZED SET SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB DEPUY SPINE INC 199721001S 10705034466149

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention 5.5 EXP VERSE CAN SCR 7.0X40| 5.5 EXP VERSE CAN SCR 7.0X40| 5.5 EXP VERSE CAN SCR 7.0X50| 5.5 EXP VERSE CAN SCR 7.0X50| 5.5 EXP VERSE UNITIZED SET SCR| MMSI ROD, 5.5 X 55MM, TI| MMSI ROD, 5.5 X 55MM, TI| SFX,5.5,TI, MED, SIZE A5| T-PAL PROTI, 10X10X28 MM