BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS,PEDICLE SPINAL FIXATION

    MDR report key: 5274884 · Received December 8, 2015

    Report

    Report Number
    2520274-2015-17729
    Event Type
    Injury
    Date Received
    December 8, 2015
    Report Date
    November 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS: (B)(6). THIS REPORT IS FOR TWO UNKNOWN USS SCREWS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. POTENTIAL SCREW PART NUMBERS OF 498.540, 498.740 AND 498.863 WERE PROVIDED, BUT IT IS UNKNOWN WHICH WERE THE INVOLVED SCREWS. PART 498.540 5.0MM TI SIDE-OPENING SCREW 40MM; PRODUCT CODES: KWP, MNH, MNI; 510K: K141897. PART 498.740 7.0MM TI SIDE-OPENING SCREW 40MM; PRODUCT CODES: KWP, MNH, MNI; 510K: K141897. PART 498.863 8.0MM TI SIDE-OPENING SCREW 45MM; PRODUCT CODES: NKB, MNI, MNH, KWP, KWQ; 510K: K082572. ORIGINAL IMPLANT DATE FOR L2-S1 POSTERIOR FUSION WAS (B)(6) 2014. (B)(4). 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A REVISION SURGERY RELATED TO AN L2-S1 POSTERIOR LUMBAR FUSION WITH SYNTHES UNIVERSAL SPINAL SYSTEM (USS) DEVICES IN (B)(6) 2014. AT AN UNKNOWN POINT IN TIME, THE PATIENT DEVELOPED ADJACENT LEVEL STENOSIS AND DISC DISEASE ABOVE THE LEVEL OF THE FUSION; IT WAS ALSO NOTED THE PATIENT EXPERIENCED PAIN, IRRITATION AND/OR DISCOMFORT. THERE WAS NO ISSUE WITH THE HARDWARE FROM THE (B)(6) 2014 PROCEDURE. THE SURGEON REMOVED THE RODS, AND REMOVED AND REPLACED SIX (6) OF THE EIGHT (8) SCREWS THAT WERE IMPLANTED IN THE (B)(6) 2014 PROCEDURE (NO SCREWS WERE PLACED IN L5 AT THE TIME). IT IS UNKNOWN WHICH SCREWS FROM THE (B)(6) 2014 PROCEDURE WERE REMOVED AND REPLACED. THIS REPORT IS FOR TWO UNKNOWN USS SCREWS. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805876 ORTHOSIS,PEDICLE SPINAL FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention