BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE

    MDR report key: 2944934 · Received February 6, 2013

    Report

    Report Number
    2530088-2013-00113
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    October 2, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE PARTS MET SPECIFICATIONS. THERE WERE VISUAL NON CONFORMANCES NOTED THAT DID NOT AFFECT THE FINAL PRODUCT SPECIFICATIONS OF THE INLAY. THEY WERE ADDRESSED ON MATERIAL REVIEW RECORDS: MRRS 53832 AND 54273 SCREENED AND SORTED RAW MATERIAL FOR STRAIGHTNESS. MATERIAL THAT DID NOT MEET INSPECTION REQUIREMENTS WERE RETURNED TO THE VENDOR. MRR 55314 REWORKED RAW MATERIAL THAT WAS FOUND TO BE BOWED. MATERIAL WAS CUT TO SHORTER LENGTHS TO REMOVE THE BOW AND RE INSPECTED. MRR 100277 DISPOSITIONED 3 POUNDS OF RAW MATERIAL FOUND TO BE OUT OF ROUND, ONE AND A HALF POUNDS WERE SCRAPPED.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PATIENT WAS TRAINING AS A JUVENILE PROBATION OFFICER WHEN SHE WAS DROPPED INTO A SITTING POSITION AND BEGAN HAVING SEVERE LOW BACK PAIN. SHE THEN DEVELOPED THORACIC PAIN AND CERVICAL PAIN. PATIENT WAS TREATED WITH PHYSICAL THERAPY, STIMULATION, MASSAGE THERAPY INTERVENTIONS AND ACUPUNCTURE. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH PRODISC-L AT L4-5 AND L5-S1 FOR L4-5 AND L5-S1 DEGENERATIVE DISC DISEASE. AT THE TIME OF THE IMPLANTATION, THE PATIENT, WHO WAS (B)(6), WAS EXPERIENCING SEVERE BACK PAIN, 7-10 OUT OF 10 IN THE LOW BACK, SEVERE IN THE LUMBOSACRAL AREA RADIATING DOWN BOTH LEGS ... AND RIGHT-SIDED RADICULOPATHY. SHE ALSO HAD LEFT-SIDED SYMPTOMS WHICH WERE MORE SIGNIFICANT AND WALKING WAS DIFFICULT FOR HER. SHE HAD NOT RETURNED WORK AND WAS TAKING WELLBUTRIN FOR DEPRESSION AND VICODIN AND FLEXERIL AS NEEDED. IN ADDITION, SHE HAS A HISTORY OF SMOKING A COUPLE OF CIGARETTES A DAY, A RECENT MISCARRIAGE, AND A 25-POUND WEIGHT GAIN. A SYNTHES REPRESENTATIVE WAS PRESENT FOR THE IMPLANTATION PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE IMPLANTATION PROCEDURE AND RADIOLOGY FILMS SHOWED ADEQUATE PLACEMENT OF THE INSTRUMENTATION. THE PATIENT HAD A PANIC ATTACK ON POSTOPERATIVE DAY 2, BUT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2010 IN STABLE CONDITION. THE PATIENT CLAIMS THAT ON (B)(6) 2010 SHE BECAME AWARE THAT THE SURGERY HAD FAILED. ACCORDING TO THE PATIENT, THE ARTIFICIAL DISC AT L4-5 MOVED AND FAILED CAUSING THE PATIENT CONSTANT PAIN AND REQUIRED FURTHER SURGERY AND IN-HOME SUPPORT SERVICES. THE PATIENT ASSERTS AFTER THE SURGERY FAILED, THE SURGEON FIRST TESTED HER FOR OSTEOPENIA, AN ALLEGED CONTRAINDICATION FOR SURGERY. SHE ALSO CLAIMS THAT SHE SUFFERED FROM BONY LUMBAR SPINAL STENOSIS AND ISOLATED RADICULAR COMPRESSION SYNDROMES, WHICH SHE ASSERTS WERE CONTRAINDICATIONS FOR THE PROCEDURE. THIS IS 1 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50787 POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE POLYETHYLENE INLAY MJO SYNTHES BRANDYWINE 6001538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention