BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM

    MDR report key: 1396338 · Received May 29, 2009

    Report

    Report Number
    1810189-2009-00007
    Event Type
    Injury
    Date Received
    May 29, 2009
    Report Date
    May 21, 2009
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: SPINE. AUTHOR: DIRK H. ALANDER, MD. TITLE: GELFOAM - INDUCED ACUTE QUADRIPARESIS AFTER CERVICAL DECOMPRESSION AND FUSION. VOLUME: 20 YEAR: 1995. PAGES: 970-971.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) WRONG TECHNIQUE IN DRUG USAGE PROCESS [WRONG TECHNIQUE IN DRUG USAGE PROCESS] C5 INCOMPLETE FRANKEL B QUADRIPLEGIA [QUADRIPLEGIA] CASE DESCRIPTION: THIS IS A DEVICE LITERATURE CASE REPORT FROM THE SPINE JOURNAL, 195, VOLUME 20, NUMBER 8, PAGES 970-971. A FEMALE HAD A C5 AND C6 CORPECTOMY, WITH FIBULAR STRUT GRAFTING FOR SEVERE SPONDYLOSIS AND MYELOPATHY. POST-OPERATIVELY SHE WAS FOUND TO BE QUADRIPARETIC. ON ADMISSION TO THE SPINAL CORD UNIT, PHYSICAL EXAMINATION REVEALED A C5 INCOMPLETE FRANKEL B QUADRIPLEGIA. A PLAIN RADIOGRAPH REVEALED A WELL-PLACED INTERBODY FIBULAR GRAFT FROM C4-C7. A MAGNETIC RESONANCE IMAGE OF THE CERVICAL SPINE REVEALED A LARGE MASS BETWEEN THE FIBULAR GRAFT AND SPINAL CORD WITH SEVERE SPINAL CORD COMPRESSION. THE PATIENT UNDER-WENT ANTERIOR SURGICAL DECOMPRESSION, AND A SWOLLEN MASS OF BLOOD-SOAKED GELFOAM, THE LENGTH AND WIDTH OF THE CORPECTOMY SITE, WAS REMOVED. AFTER SURGERY, THE PATIENT RECOVERED TO A FRANKEL D C5 INCOMPLETE CORD LESION AND RETURNED HOME, REQUIRING MODERATE ASSISTANCE IN ACTIVITIES OF DAILY LIVING. IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. A REVIEW OF PFIZER'S SAFETY DATABASE FOR CASES RECEIVED THROUGH 15 MAY 2009 IDENTIFIED NO SERIOUS CASES FROM SOLICITED SOURCES AND CLINICAL STUDIES REPORTING GELFOAM OR BLINDED THERAPY AND ADVERSE EVENTS ENCODING TO THE MEDDRA (VERSION 12.0) PREFERRED TERM QUADRIPLEGIA. IN ADDITION, NO CASES REPORTED FROM NON-CLINICAL STUDY SOURCES REPORTING QUADRIPLEGIA WERE IDENTIFIED DURING THIS PERIOD WITH GELFOAM. CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THE CASE, THE REPORTED EVENT OF C5 INCOMPLETE FRANKEL B QUADRIPLEGIA (ACUTE QUADRIPARESIS) MOST LIKELY REPRESENTED SEQUELAE TO POSTOPERATIVE CERVICAL SURGERY WHERE GELFOAM WAS USED FOR HEMOSTASIS DURING SURGERY. AS DESCRIBED IN THIS CASE, A POSSIBLE CONTRIBUTORY ROLE OF GELFOAM TO CAUSE NEUROLOGICAL COMPROMISE CANNOT BE COMPLETELY EXCLUDED DUE TO A POTENTIAL FOR EXPANSION OF THE GELFOAM SPONGE IN ENCLOSED SPACES AFTER SPINAL SURGERY. OTHER COMPLICATIONS FOLLOWING SPINE SURGERY (C5 AND C6 CORPECTOMY, WITH FIBULAR STRUT GRAFTING) COULD ALSO BE CONTRIBUTING FACTORS TO THE CLINICAL PRESENTATION OF THIS PATIENT. AT THE CONCLUSION OF SURGERY AS GELFOAM INTENDED FOR HEMOSTASIS WAS NOT REMOVED, WRONG TECHNIQUE IN DRUG USAGE PROCESS IS BEING PULLED AS AN EVENT. BASED ON THE INFORMATION PROVIDED IN THE CASE, THIS INDIVIDUAL REPORT WOULD NOT SEEM TO MODIFY THE RISK-BENEFIT PROFILE OF THE SUBJECT DEVICE. THE NEED FOR CORRECTIVE ACTION IS BEING EVALUATED AND WILL BE COMMUNICATED IN THE FINAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R| S