BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTOR

    MDR report key: 4916242 · Received July 15, 2015

    Report

    Report Number
    2520274-2015-14922
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    July 8, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. J., WOITZIK, LOHKAMP, L.-N., CZABANKA, M., AND VAJKOCZY, P. (2013). MINIMAL INVASIVE RETRO-PLEURAL APPROACH FOR TREATMENT OF THORACIC SPINAL PATHOLOGIES. EUROPE SPINE, 22, 2237-2238. THIS REPORT IS FOR UNKNOWN SYNFRAME AND UNKNOWN LOT NUMBERS. (B)(6). (B)(4) PLEURA INJURIES. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    ABSTRACT RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ABSTRACT J., WOITZIK, LOHKAMP, L.-N., CZABANKA, M., AND VAJKOCZY, P. (2013). MINIMAL INVASIVE RETRO-PLEURAL APPROACH FOR TREATMENT OF THORACIC SPINAL PATHOLOGIES. EUROPE SPINE, 22, 2237-2238. A MINIMAL INVASIVE RETRO-PLEURAL APPROACH TO THE ANTERIOR THORACIC SPINE WAS PERFORMED ON 14 PATIENTS WITH THORACIC SPINE METASTASES (N=6), DISC HERNIATION (N=3) OR VERTEBRAL FRACTURES (N=5) BETWEEN 2012 AND 2013. AFTER LATERAL POSITIONING OF THE PATIENT, RETRO-PLEURAL PREPARATION WAS PERFORMED DURING ONE-SIDED PULMONARY VENTILATION, WHICH WAS DEREGULATED AFTER INSERTION OF DISTRACTION INSTRUMENTS (SYNFRAME). TEN FEMALE AND FOUR MALE PATIENTS BETWEEN 48 AND 78 YEARS (MEDIAN=66 YEARS) WERE TREATED WITH THE MINIMAL INVASIVE RETRO-PLEURAL APPROACH. IN EVERY CASE A SUFFICIENT PREPARATION AND EXPOSURE WAS ACHIEVED. OPERATIVE RESULTS, COMPLICATIONS AND EARLY POSTOPERATIVE OUTCOME WERE ASSESSED. IN 5 PATIENT'S INJURY OF THE PLEURA OCCURRED WHICH WAS LOCALLY SUTURED IN 3 PATIENTS AND TREATED BY THORAX DRAINAGE PLACEMENT IN TWO PATIENTS. THIS REPORT IS REGARDING UNKNOWN SYNFRAME DEVICES CONCERNING FIVE (5) PLEURA INJURIES. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNFRAME CONCERNING PLEURA INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458499 RETRACTOR GAD SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention