BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 100MM

    MDR report key: 3792062 · Received May 6, 2014

    Report

    Report Number
    2530088-2014-10104
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    PK992739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR) INDICATED THAT THE REPORTED PRODUCT P/N 498.104, LOT# 6667871 WAS MANUFACTURED ON 09/02/2011 IN ACCORDANCE WITH ALL ESTABLISHED PROCESS REQUIREMENTS, WITH NO PROCESS DEVIATIONS OR NONCONFORMITIES REPORTED. THE DHR FOR THE REPORTED PRODUCT FURTHER INDICATED THAT THE PRODUCT LOT WAS VERIFIED AS CONFORMING TO ALL PERTINENT DIMENSIONAL, VISUAL, AND FUNCTIONAL REQUIREMENTS IN ACCORDANCE WITH ESTABLISHED PROCEDURES WITH NO PRODUCT NONCONFORMITIES REPORTED. THE DHR FOR THE REPORTED PRODUCT SHOWS THAT THE PRODUCT WAS PRODUCED FROM RAW MATERIAL P/N 21100, LOT# 6510513 IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS. DEVICE HISTORY RECORDS FOR RAW MATERIAL P/N 21100, LOT# 6510513 WERE REVIEWED AND FOUND TO TIE BACK TO P/N 21100, LOT# 6496121, WHICH WAS TO BE ETCHED AS LOT# 6510513. LOT# 6496121 WAS SORTED FROM P/N 21008, LOT# 5203633 PER NCR (B)(4). WHICH WAS INITIATED IN RESPONSE TO DETECTION OF OVERSIZED OD AND SURFACE FINISH ISSUES (VISIBLE SCRATCHES AND GRIND MARKS) ON THE RAW MATERIAL. RAW MATERIAL THAT MET THE TIGHTER OD TOLERANCE FOR P/N 21100 WAS SORTED OUT AND EVENTUALLY ETCHED AS LOT# 6510513. RAW MATERIAL THAT DID NOT MEET THE TIGHTER TOLERANCE REMAINED AS P/N 21008, LOT# 5203633. AS A RESULT, THEY WERE DISPOSITIONED AS CONFORMS RELATIVE TO THEIR NEW PART NUMBER SPECIFICATIONS. THE NONCONFORMANCE REPORT (NCR) FOR SORTING AND REWORK ARE NOT RELEVANT TO THE REPORTED COMPLAINT CONDITION BECAUSE, PER THE SPECIFIED INSPECTION ACTIVITIES, THE RAW MATERIAL MET ALL ESTABLISHED REQUIREMENTS FOR USE AS INTENDED. RAW MATERIAL INSPECTION AND TEST RECORDS FOR P/N 21008, LOT# 5203633 INDICATE THAT THE MATERIAL MET ALL ESTABLISHED CHEMICAL AND PHYSICAL REQUIREMENTS FOR BOTH P/N 21008 AND 21100. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: MNI. IMPLANT DATE: ORIGINAL IMPLANT REPORTED AS ONLY (B)(6) 2013. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 A PATIENT HAD A REMOVAL/REVISION SURGERY OF UNIVERSAL SPINE SYSTEM (USS) HARDWARE DUE TO POSTOPERATIVE PATIENT PAIN ON (B)(6), 2014. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2013 TO TREAT A PELVIC FRACTURE. IT WAS OBSERVED ON AN UNKNOWN DATE THAT THE PATIENT HAD A BROKEN ROD ON THE LEFT SIDE BETWEEN THE S1 AND ILIAC SCREW LEVELS. THE PATIENT HAD A BROKEN LEFT ILIAC SCREW. THE SCREW WAS BROKEN OFF AT THE BASE OF THE HEAD OF THE USS SCREW. SURGEON ADDITIONALLY REPORTED THAT THE PATIENT HAD A SACRAL NON-UNION. SURGEON EXPLANTED ALL THE USS HARDWARE WITH THE EXCEPTION OF THE LEFT ILIAC SCREW FRAGMENT THAT THE SURGEON WAS UNABLE TO REMOVE. SURGEON COMMENTED THAT THE NUTS ON BOTH S1 LEVEL SEEMED LOOSE DURING EXPLANT. SURGEON REVISED THE PATIENT TO NEW 1.0MM LARGER DIAMETER SCREWS AT THE L4, L5 AND S1 LEVEL POSITIONS. ALL REVISED SCREWS WERE 1.0MM LARGER DIAMETER THAN THE ONES THAT WERE REMOVED. THE SURGEON REPLACED THE RIGHT ILIAC SCREW WITH THE SAME 8.0 X 120MM SCREW HE REMOVED, FOR THE LEFT ILIAC SCREW POSITIONED NEXT TO THE BROKEN SCREW, THE SURGEON PLACED A 7.0 X 100MM ALONG THE BROKEN SCREW. THE SURGEON ALSO REVISED PATIENT WITH NEW RODS AND COMPLETED THE PROCEDURE SUCCESSFULLY. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270281 6.0MM TI HARD ROD 100MM ORTHOSIS,SPONDYLOSTHESIS MNH SYNTHES BRANDYWINE 6667871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention