BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8611852 · Received May 15, 2019

    Report

    Report Number
    8030965-2019-63971
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    April 16, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KLONZ A, HABERMEYER P (2007). ARTHRODESIS OF THE SHOULDER. A NEW AND SOFT-TISSUE-SPARING TECHNIQUE WITH A DEEP LOCKING PLATE IN THE SUPRASPINATOUS FOSSA. DER UNFALLCHIRURG. VOLUME 110. NUMBER 10. PAGE 891-895. (GERMANY). THIS STUDY PRESENTS AN OPERATIVE TECHNIQUE THAT HAS NEVER BEEN DESCRIBED BEFORE WHICH COMBINES INTRA AND EXTRA-ARTICULAR ARTHRODESIS WITH PRIMARY COMPRESSION OF THE ARTHRODESIS SPACE USING SCREWS AND AN ADDITIONAL FIXED-ANGLE NEUTRALIZATION PLATE. THIS IS A CASE REPORT OF THE (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN OPEN ACROMIOPLASTY AND AN OPEN REVISION OF THE SUPRASCAPULAR NERVE 5 YEARS PREVIOUSLY. THE OPERATION LED TO A MASSIVE SUBSTANCE DEFECT TO THE ACROMION AND PARALYSIS OF THE SUPRASPINATUS AND INFRASPINATUS MUSCLES, AS WELL AS A DELTOID INSUFFICIENCY. A RECONSTRUCTION ATTEMPT WAS CARRIED OUT USING A DELTOID TRANSPOSITION FLAP. IN 2003, GIVEN THE ONGOING SEVERE PAIN AND INCREASING ALGODYSTROPHY, THE PATIENT UNDERWENT AN INITIAL ARTHRODESIS WITH SMALL FRAGMENT SCREWS AND FIXED-ANGLE BOLTS USING AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE. THIS CREATED A SATISFACTORY LEVEL OF STABILITY ¿ THE PATIENT¿S PAIN IMPROVED CONSIDERABLY, BUT DID NOT COMPLETELY DISAPPEAR. FOR THE LAST YEAR, SHE HAS BEEN COMPLAINING AGAIN OF INCREASING, AND RECENTLY, SEVERE PAIN EVERY TIME SHE MOVES HER BODY. SCANS SHOWED A PSEUDARTHROSIS WITH NO BREAK IN THE SMALL FRAGMENT SCREWS. PATIENT UNDERWENT REVISION WITH THE REMOVAL PHILOS PLATE. THE REMOVAL WAS DIFFICULT AS SOME SCREWS WERE COLD-FUSED AND NEEDED TO BE DRILLED OUT. THE SCREWS WERE PARTLY LEFT IN THE BONE IN ORDER NOT TO FURTHER WEAKEN THE BONE BED. THE PATIENT WAS THEN IMPLANTED WITH AN UNKNOWN SYNTHES 4.5-MM LOCKING COMPRESSION PLATE. POST-OPERATION, THE PATIENT WAS COMPLETELY PAIN-FREE. AFTER 3 MONTHS, THE ARTHRODESIS WAS BUILT UP AS WIDELY AS POSSIBLE AND THE ACTIVE MOVEMENT (30 DEGREES FLEXION AND 30 DEGREES ABDUCTION) WAS SEVERELY LIMITED AGAIN, WHICH WAS ATTRIBUTABLE TO THE PREVIOUS LONG PERIOD OF SUFFERING WITHOUT THE BUILT-UP ARTHRODESIS. THIS REPORT CAPTURES CAPTURE THE REPORTED PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE AND SCREWS WITH THE FOLLOWING ADVERSE EVENTS: SEVERE PAIN, PSEUDOARTHROSIS. THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406071 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention