BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3894975 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-11782
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 3, 2012
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SEVEN UNIDENTIFIED PATIENTS. RADIOGRAPHIC CHANGES OF IMPLANT FAILURE AFTER PLATING FOR PUBIC SYMPHYSIS DIASTASIS: AN UNDERAPPRECIATED REALITY?; BY COLLINGE, CORY, MD; ARCHDEACON, MICHAEL T., MD; DULANEY-CRIPE, ELIZABETH, MD AND MOED, BERTON R., MD. THIS REPORT IS FOR AN UNKNOWN PLATE. PRODUCT AND LOT NUMBER ARE UNKNOWN. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN RECEIVED FROM A LITERATURE ARTICLE: RADIOGRAPHIC CHANGES OF IMPLANT FAILURE AFTER PLATING FOR PUBIC SYMPHYSIS DIASTASIS: AN UNDERAPPRECIATED REALITY?; BY COLLINGE, CORY, MD; ARCHDEACON, MICHAEL T., MD; DULANEY-CRIPE, ELIZABETH, MD AND MOED, BERTON R., MD. THIS IS A RETROSPECTIVE REVIEW OF 165 PATIENTS TREATED AT TWO REGIONAL LEVEL I AND ONE LEVEL II TRAUMA CENTERS WITH PLATE FIXATION FOR ACUTE DISRUPTION OF PUBIC SYMPHYSIS BETWEEN AUGUST 2002 AND JULY 2006. ALL DATA WAS OBTAINED FROM PROSPECTIVELY COLLECTED TRAUMA DATABASES, MEDICAL RECORDS, AND RADIOGRAPHS. SPECIFICALLY THE AUTHORS SOUGHT TO INVESTIGATE RADIOGRAPHIC CHANGES OCCURRING AT THE SYMPHYSEAL REPAIR AND IN BONY ALIGNMENT AT THE PUBIC SYMPHYSIS. PLATING WAS PERFORMED USING A FOUR- OR SIX-HOLE PLATE AND 3.5 MM SCREWS (COMPETITOR OR SYNTHES¿ RECONSTRUCTION ®, PAOLI, PA, USA). THIS PLATE IS SIMILAR TO A CONTOURED STAINLESS STEEL 3.5 MM RECONSTRUCTION PLATE THAT IS REINFORCED AT THE MIDDLE SYMPHYSEAL PORTION WITH ADDITIONAL MATERIAL TO AVOID FAILURE THERE. THE PLATE ACCEPTS 3.5 MM SCREWS AND 4.5 MM SCREWS, ALTHOUGH ALL THREE REPORTING SURGEONS IN THIS STUDY HAVE PREFERRED USING THE FORMER UNLESS A SCREW HAS BEEN STRIPPED REQUIRING REVISION TO A LARGER SCREW. THE END POINT FOR FOLLOW-UP WAS A CLINICALLY HEALED INJURY, MALUNION, FAILURE OF FIXATION, OR REOPERATION ON THE ANTERIOR RING. NINETY-FIVE OF THE 126 PATIENTS INCLUDED FOR THE STUDY HAD RADIOGRAPHIC FAILURE OF FIXATION IN THE FORM OF SCREW LOOSENING AND /OR BREAKAGE OF THEIR SYMPHYSEAL FIXATION BY LAST FOLLOW-UP. SIXTY-SEVEN PATIENTS HAD ONLY LOOSE SCREWS, FIVE HAD ONLY SCREW BREAKAGE, 16 HAD SOME SCREWS LOOSEN AND OTHERS THAT BROKE, AND SEVEN HAD BROKEN PLATES. SEVENTY-TWO PATIENTS PRESENTED WITH FIXATION FAILURE AND PUBIC SPACE WIDENING OF 2-9 MM; WHILE SEVEN PATIENTS PRESENTED WITH FIXATION FAILURE AND PUBIC SPACE WIDENING OF GREATER THAN OR EQUAL TO 10 MM. COMPLICATIONS RELATING TO SYMPHYSIS INJURY AND REPAIR INCLUDED REOPERATION ON ONE OF THE SEVEN PATIENTS¿ AFTER FAILURE OF FIXATION WITH RECURRENT WIDENING OF THE PUBIC SYMPHYSIS TO 20 MM. ONE PATIENT HAD AN ACUTE POSTOPERATIVE WOUND INFECTION AND ONE HAD EARLY DEHISCENCE, BOTH TREATED WITH SURGICAL IRRIGATION AND DEBRIDEMENT, RETENTION OF IMPLANTS, AND SECONDARY WOUND CLOSURE. THE PATIENT WITH THE INFECTION WAS TREATED WITH SIX WEEKS OF UNSPECIFIED ANTIBIOTICS. BOTH PATIENTS¿ WOUNDS HEALED WITHOUT FURTHER PROBLEMS. TWO PATIENTS HAD IMPLANTS ELECTIVELY REMOVED. ONE WAS A YOUNG WOMAN WHO DESIRED PLATE REMOVAL WITH THE RATIONALE THAT IT MIGHT AVERT POTENTIAL PROBLEMS WITH CHILDBIRTH, AND THE OTHER WAS A MAN WHO HAD A SINGLE, LOOSE SYMPTOMATIC SCREW AND AN ADDITIONAL SCREW THAT HAD BACKED OUT SEVERAL CENTIMETERS. AN ILLUSTRATIVE CASE OF A (B)(6) MAN INJURED IN A MOTORCYCLE CRASH REVEALED A LOSS OF FIXATION BY MEANS OF SEPARATION OF THE SCREW HEADS AND THE PLATE AND WIDENING OF THE PUBIC SPACE TO 7.6 MM AT HIS 26 MONTH FOLLOW-UP. ACCORDING TO THE AUTHORS, FAILURE OF SYMPHYSEAL FIXATION IN MANY CASES MAY SIMPLY REPRESENT RELAXATION OF THE IMPLANTS AS PHYSIOLOGICAL MOTION IS RESTORED TO THE PELVIS. HOWEVER THE CLINICAL RELEVANCE REMAINS UNDEFINED. TO DATE THERE IS NO DATA CONCERNING THE NATURAL HISTORY OF PELVIC MOTION AFTER PELVIC RING INJURY AND REPAIR OR CORRELATING CLINICAL OUTCOMES WITH THIS RESIDUAL PELVIC MOTION. THEREFORE THE AUTHORS BELIEVE PATIENTS SHOULD BE COUNSELED REGARDING THE POSSIBILITY OF RADIOGRAPHIC ANTERIOR PELVIC PLATE FIXATION FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR 7 PATIENTS WITH PLATE BREAKAGE. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370807 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention