BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10434809 · Received August 20, 2020

    Report

    Report Number
    8030965-2020-06211
    Event Type
    Injury
    Date Received
    August 20, 2020
    Report Date
    July 28, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - CONSTRUCTS: PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (B)(4) 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KWAK, J.M. AND JUNG, G.H. (2018), BIOLOGIC PLATING OF UNSTABLE DISTAL RADIAL FRACTURES, BMC MUSCULOSKELETAL DISORDERS, VOL. 19(117), PAGES 1-8 (SOUTH KOREA) HTTPS://DOI.ORG/10.1186/S12891-018-2046-2 THIS STUDY DESCRIBES OUR PROSPECTIVE EXPERIENCE WITH BRIDGE PLATING THROUGH INDIRECT REDUCTION. FROM JUNE 2006 TO DECEMBER 2010, A TOTAL OF 33 WRISTS OF 29 PATIENTS UNDERWENT BRIDGE PLATING THROUGH A PQ-SPARING APPROACH WITH INDIRECT REDUCTION. THERE WERE 12 MALES AND 16 FEMALES WITH A MEAN AGE OF 56.8 YEARS (RANGE, 25¿83 YEARS). IMPLANTS USED WAS A 2.4 MM VOLAR DISTAL RADIUS PLATING SYSTEM (LDRS®; SYNTHES, OBERDORF, SWITZERLAND). EACH PATIENT WAS FOLLOWED UP FOR MORE THAN 36 MONTHS AFTER SURGERY. THE MEAN FOLLOW-UP DURATION WAS 47.5 MONTHS (RANGE, 36¿67 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS WERE LOST DURING FOLLOW-UP BECAUSE OF DEATH (1 SUICIDE AND 1 CAR ACCIDENT). DESPITE CLOSED MANEUVERS AND A SURGICAL DELAY OF MORE THAN 2 WEEKS IN FOUR PATIENTS, EXTRA-ARTICULAR REALIGNMENT WAS ACHIEVED USING THE ABOVE TECHNIQUE, WITH ALL ARTICULAR FRACTURES SHOWING RESTORATION OF JOINT INCONGRUITY TO < 2 MM AND SIGNIFICANT RESTORATION OF ALL RADIOLOGIC PARAMETERS SUFFICIENT FOR STATISTICAL SIGNIFICANCE. RADIOGRAPHS TAKEN AT THE FINAL VISIT REVEALED THAT THE RADIOLOGIC PARAMETERS WERE WELL MAINTAINED, EXCEPT FOR SLIGHT LOSSES OF RADIAL LENGTH AND RADIAL INCLINATION IN SOME WRISTS. 1 PATIENT WITH A C2 FRACTURE HAD ARTICULAR GAPS < 2 MM. THE PATIENT WITH SIGNIFICANT ARTICULAR INCONGRUITY DID NOT WISH TO UNDERGO A SECOND OPERATION BECAUSE OF ASSOCIATED INJURY TO THE HEAD AND ABDOMEN. 3 PATIENTS HAD FAIR OVERALL OUTCOMES. 3 PATIENTS WITH EXCESSIVE RADIAL LENGTH EXPERIENCED MILD PAIN IN THE DISTAL RADIO-ULNAR JOINT AT THE FIRST OUTPATIENT FOLLOW-UP VISIT. COMPARED WITH THE AVERAGE RUI, THE RUIS DIFFERED AFTER SURGERY IN THESE PATIENTS BY 4.0, 4.0 AND 5.0 MM, DIFFERENCES THAT WERE SIGNIFICANT. PAIN IN ALL 3 OF THESE PATIENTS RESOLVED WITHIN 6 MONTHS. 5 PATIENTS DEVELOPED POSTOPERATIVE COMPLICATIONS RELATED TO INDIRECT REDUCTION -2 PATIENTS HAD INSUFFICIENT REDUCTION OF THE DISTAL ARTICULAR ANGLE THAT WAS NOT FULLY RESTORED TO VOLAR TILT BY INDIRECT METHODS -3 PATIENTS EXPERIENCED TRANSIENT PAIN IN THE DISTAL RADIOULNAR JOINT DUE TO RADIAL LENGTH OVERCORRECTION. THIS REPORT IS FOR AN UNKNOWN SYNTHES 2.4 MM VOLAR DISTAL RADIUS PLATING SYSTEM (LDRS®; SYNTHES, OBERDORF, SWITZERLAND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894974 UNK - CONSTRUCTS: PLATE/SCREWS SCREW,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention