BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4898555 · Received July 8, 2015

    Report

    Report Number
    2520274-2015-14831
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    April 23, 2013
    Report Date
    June 24, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORT IS FOR UNKNOWN - STAINLESS SCREW SYSTEM OR TICP SCREW SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). REFERS TO ONE PATIENT WITH NEUROLOGICAL DEFICIT STILL PERSISTING, TWO PATIENT WHO HAD VERTEBRAL INJURY ONE PATIENT WHO HAD DURA LACERATION DURING INSERTION OF TRANSARTICULAR SCREW INTRA-OPERATIVELY. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, SUTIPORNPALANGKUL, W. AND THANAPIPATSIRI, S. (2013) ATLANTOAXIAL TRANSARTICULAR SCREW FIXATION AND POSTERIOR FUSION USING POLYESTER CABLE: A 10-YEAR EXPERIENCE. EUR SPINE J, 22: 1564-1569. THE PURPOSE OF THIS ARTICLE WAS A RETROSPECTIVE REVIEW OF THE CLINICAL OUTCOMES OF THE MODIFIED OPERATIVE TECHNIQUE USING A POLYESTER SUTURE MATERIAL FOR ATLANTOAXIAL TRANSARTICULAR SCREW FIXATION AND POSTERIOR FUSION. THE RETROSPECTIVE REVIEWS WERE CONDUCTED FROM 2002 TO 2012. TWENTY-THREE PATIENTS DEMONSTRATED CLINICAL AND RADIOGRAPHIC EVIDENCE OF ATLANTOAXIAL INSTABILITY (13 MEN AND 10 WOMEN, WITH A MEAN AGE OF 42 YEARS) UNDERWENT C1-C2 TRANSARTICULAR SCREW AND POSTERIOR FUSION WITH ETHIBOND SUTURE. MAJORITY OF ATLANTOAXIAL INSTABILITY WAS CAUSED BY TRAUMA. MOST COMMON CLINICAL SYMPTOM WAS NECK PAIN WITH OR WITHOUT CERVICAL MYELOPATHY. BILATERAL SCREWS WERE PLACED IN 18 OF THE 23 PATIENTS. FIVE PATIENTS UNDERWENT PLACEMENT OF UNILATERAL SCREWS. THE MEAN OF FOLLOW-UP DURATION WAS 18 MONTHS. ALL 23 PATIENTS ACHIEVED FUSION (100 % FUSION RATE). AFTER A PERIOD OF FOLLOW-UP, 9 OF THE 10 NEUROLOGICAL DEFICIT PATIENTS HAD COMPLETELY RECOVERED, WITH NEUROLOGICAL DEFICIT STILL PERSISTING IN ONLY ONE PATIENT. THERE WERE THREE INTRA-OPERATIVE COMPLICATIONS DURING INSERTION OF TRANSARTICULAR SCREW, BUT NO COMPLICATION WAS ASSOCIATED WITH POSTERIOR GRAFT FIXATION USING ETHIBOND SUTURE MATERIALS. TWO PATIENTS HAD VERTEBRAL ARTERY INJURY AND ONE PATIENT HAD DURA LACERATION DURING INSERTION OF TRANSARTICULAR SCREW. THESE THREE INTRA-OPERATIVE COMPLICATIONS, HOWEVER, DID NOT CAUSE ANY SIGNIFICANT CLINICAL CONSEQUENCES. OTHER POSTOPERATIVE COMPLICATIONS INCLUDED TWO PATIENTS WHO DEVELOPED SURGICAL WOUND INFECTION AT THE POSTERIOR CERVICAL INCISION. BOTH PATIENTS WITH SURGICAL WOUND INFECTIONS WERE MANAGED EFFECTIVELY WITH DEBRIDEMENT AND INTRAVENOUS ANTIBIOTIC ADMINISTRATION. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN STAINLESS SCREW SYSTEM OR TICP SCREW SYSTEM AND REFERS TO THE SERIOUS INJURY OF: ONE PATIENT WITH NEUROLOGICAL DEFICIT STILL PERSISTING; TWO PATIENTS WITH VERTEBRAL INJURY; ONE PATIENT WITH DURA LACERATION DURING INSERTION OF TRANSARTICULAR SCREW INTRA-OPERATIVELY; AND TWO PATIENTS WHO DEVELOPED SURGICAL WOUND INFECTION AT THE POSTERIOR CERVICAL INCISION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442412 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention