BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL TAPE UNKNOWN

    MDR report key: 8966408 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86590
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: EUR J TRAUMA EMERG SURG (2008); 34:515¿21. DOI: 10.1007/S00068-008-7172-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE "TITLE : UNSTABLE CERVICAL SPINAL INJURY IN CHILDREN ¿ CASE REPORT AND REVIEW OF THE LITERATURE ". AUTHOR : MAXIMILIAN FASCHINGBAUER1, ARNDT P. SCHULZ1,2, KLAUS SEIDE1, CHRISTIAN JÜRGENS. CITATION: EUR J TRAUMA EMERG SURG (2008); 34:515¿21. DOI: 10.1007/S00068-008-7172-3. THE AUTHORS PRESENTED A CASE REPORT INVOLVING OF A (B)(6) YEAR-OLD FEMALE PATIENT WHO SUSTAINED A CERVICAL SPINAL INJURY WITH UNILATERAL FACET DISLOCATION AND DISCUSS DETAILS AND PROBLEMS OF DIAGNOSTIC PROCEDURES AND TREATMENT IN THE LIGHT OF THE RECENT LITERATURE. A (B)(6) YEAR-OLD FEMALE PATIENT SUSTAINED A ROAD TRAFFIC ACCIDENT AND COMPLAINED OF PAIN IN NECK AND LEFT HIP. X-RAYS OF THE CERVICAL SPINE SUGGESTED DISLOCATION OF THE RIGHT SIDED FACET JOINT, X-RAY OF THE PELVIS AND LEFT HIP SHOWED A SLIGHTLY DISLOCATED FRACTURE OF THE PELVIC RIM. A COMPUTER-TOMOGRAPHY (CT)-SCAN SHOWED UNILATERAL FACET DISLOCATION OF C6 ON C7 ON THE RIGHT SIDE AND A WIDENING OF THE LEFT SIDED FACET JOINT, WHICH WAS INTERPRETED AS A SUB-LUXATION. AFTER INITIAL ASSESSMENT THE PATIENT WAS TRANSFERRED TO THEATRE. CLOSED REDUCTION COULD NOT BE ACHIEVED, VIA A DORSAL APPROACH ONLY THE RIGHT FACET JOINT OF C6¿C7 WAS VISUALIZED. THE INTERSPINOUS LIGAMENT BETWEEN C6 AND C7 WAS MARKEDLY ELONGATED. WITH MANUAL TRACTION THE DISLOCATION WAS THEN REPOSITIONED. BECAUSE OF THE LIGAMENTOUS LAXITY A 3 MM VICRYL BAND (ETHICON) WAS USED AS A TENSION BAND BETWEEN THE SPINOUS PROCESS OF C6 TO C7. REPORTED COMPLICATIONS INCLUDED INCOMPLETE QUADRIPLEGIA BELOW THE LEVEL OF C6 AND COMPLETE DISLOCATION OF C6/C7 IN WHICH A COMBINED DORSOVENTRAL SPONDYLODESIS WITH CORTICO-CANCELLOUS BLOCK AND A LOCKED-IMPLANT FIXATION FROM VENTRALLY COMBINED WITH AN INTER-SPINOUS TENSION BAND WIRE C6/C7 DORSALLY WAS PERFORMED. THERE WAS COMPLETE REMISSION OF ALL NEUROLOGICAL SYMPTOMS POSTOPERATIVELY. PHYSIOTHERAPY WAS ORGANIZED ON AN OUTPATIENT BASIS. IN CONCLUSION, A MAGNETIC RESONANCE IMAGING (MRI) SEEMS ADVISABLE. A TREATMENT OF POSTOPERATIVE MALALIGNMENT WITH REPOSITION VIA A HALO-FIXATOR CANNOT BE RECOMMENDED. REPOSITIONING IS POSSIBLE BUT WAS LOST WHEN THE FIXATOR WAS REMOVED. COMPARING THE HISTORIC AND RECENT LITERATURE THERE IS ONLY WEAK EVIDENCE OVERALL, NEVERTHELESS A VENTRAL FUSION SEEMS TO BE THE TREATMENT OPTION OF CHOICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761114 VICRYL TAPE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention