BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFOAM

    MDR report key: 8585315 · Received May 7, 2019

    Report

    Report Number
    3008478369-2019-00004
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    May 17, 2018
    Report Date
    April 24, 2020
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO THE INITIAL REPORT SEND ON 17 JULY 2019. FERROSAN MEDICAL DEVICES A/S HAS RECEIVED THE OPERATIVE REPORT FROM THE PATIENT RELATED TO THE SURGERY (B)(6) 2018. IN THE REPORT IT IS STATED THAT "THE EXPOSED DURA WAS COVERED WITH GELFOAM (THIS IS REPORTED TO BE SURGIFOAM® SPONGE) AT BOTH LOCATIONS". FERROSAN MEDICAL DEVICES A/S EVALUATES THIS TO BE OFF-LABEL USE OF THE SURGIFOAM® SPONGE AS THE APPROVED INTENDED USE/INDICATIONS IS: "SURGIFOAM® SPONGE, USED DRY OR SATURATED WITH STERILE SODIUM CHLORIDE SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. ALTHOUGH NOT NECESSARY, SURGIFOAM® SPONGE CAN BE USED WITH THROMBIN TO ACHIEVE HEMOSTASIS". FURTHERMORE, AS PER THE INSTRUCTIONS FOR USE "ONLY THE MINIMUM AMOUNT OF SURGIFOAM® SPONGE NEEDED TO ACHIEVE HEMOSTASIS SHOULD BE USED. ONCE HEMOSTASIS IS ACHIEVED, ANY EXCESS SURGIFOAM® SPONGE SHOULD BE CAREFULLY REMOVED". FERROSAN MEDICAL DEVICES A/S HEREBY CLOSES THE CASE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP REPORT TO THE INITIAL REPORT. FERROSAN MEDICAL DEVICES A/S HAS RECEIVED THE OPERATIVE REPORT FROM THE PATIENT RELATED TO THE SURGERY (B)(6) 2018. IN THE REPORT IT IS STATED THAT "THE EXPOSED DURA WAS COVERED WITH GELFOAM (THIS IS REPORTED TO BE SURGIFOAM® SPONGE) AT BOTH LOCATIONS". FERROSAN MEDICAL DEVICES A/S EVALUATES THIS TO BE OFF-LABEL USE OF THE SURGIFOAM® SPONGE AS THE APPROVED INTENDED USE/INDICATIONS IS: "SURGIFOAM® SPONGE, USED DRY OR SATURATED WITH STERILE SODIUM CHLORIDE SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. ALTHOUGH NOT NECESSARY, SURGIFOAM® SPONGE CAN BE USED WITH THROMBIN TO ACHIEVE HEMOSTASIS". FURTHERMORE, AS PER THE INSTRUCTIONS FOR USE "ONLY THE MINIMUM AMOUNT OF SURGIFOAM® SPONGE NEEDED TO ACHIEVE HEMOSTASIS SHOULD BE USED. ONCE HEMOSTASIS IS ACHIEVED, ANY EXCESS SURGIFOAM® SPONGE SHOULD BE CAREFULLY REMOVED". FERROSAN MEDICAL DEVICES A/S HEREBY CLOSES THE CASE.

    Additional Manufacturer Narrative · 1

    A NUMBER OF CLINICAL QUESTIONS HAVE BEEN ASKED, IN PARTICULAR ANY HISTORY OF REPEATED SPINAL SURGERY, A REQUEST FOR THE OPERATIVE REPORT, A DESCRIPTION OF ANY INVESTIGATIONS DONE POST-OPERATIVELY, SUCH AS CT SCAN, MRI ETC. AND ANY PHYSICIAN/SURGEON NOTES FROM THE POST-OPERATIVE PERIOD. NO INFORMATION HAS BEEN RECEIVED. THE PATIENT REPORTS TO HAVE UNDERGONE A CERVICAL THORACIC LAMINECTOMY IN (B)(6) 2018. AT THIS POINT OF TIME DUE TO LACK OF INFORMATION IT IS NOT POSSIBLE TO ASSESS THE CAUSE FOR THE PARALYSIS, I.E. IF IT IS RELATED TO THE SURGERY OR THE SURGIFOAM® SPONGE. IT CAN BE NOTED THAT ACCORDING TO THE PATIENT: "WHEN THE PATIENT WOKE UP, PATIENT FOUND THAT HE HAD PARALYZED WHICH ACCORDING TO THE PATIENT WAS DISCOVERED POST-OPERATIVELY" WHICH MAY POINT TO THE SURGICAL PROCEDURE AS THE CAUSE FOR THIS EVENT. ANY OPERATION ON THE SPINE COMES WITH THE RISK OF DAMAGING THE NERVES WHICH CAN CAUSE NUMBNESS OR EVEN PARALYSIS. DETAILED INFORMATION ABOUT THE SURGICAL PROCEDURE IS ALSO UNKNOWN, I.E. FOR INSTANCE IF THE SURGICAL APPROACH WAS POSTERIOR OR ANTERIOR. IN GENERAL SPINAL NERVE INJURIES AND PARALYSIS CAN BE CAUSED BY A NUMBER OF DIFFERENT PROBLEMS INCLUDING: BLEEDING INSIDE THE SPINAL COLUMN (EXTRADURAL SPINAL HAEMATOMA); LEAKING OF SPINAL FLUID (INCIDENTAL DUROTOMY); ACCIDENTAL DAMAGE TO THE BLOOD VESSELS THAT SUPPLY THE SPINAL CORD WITH BLOOD; ACCIDENTAL DAMAGE TO THE NERVES WHEN THEY ARE MOVED DURING SURGERY. IN TERMS OF THE USE OF SURGIFOAM® SPONGE: THE USE OF THE DEVICE IS UNKNOWN IN THIS AFOREMENTIONED PROCEDURE REPORTED BY THE PATIENT. HOWEVER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: WARNINGS: SURGIFOAM® SPONGE SHOULD BE REMOVED IF POSSIBLE ONCE HEMOSTASIS HAS BEEN ACHIEVED BECAUSE OF THE POSSIBILITY OF DISLODGMENT OF THE DEVICE OR COMPRESSION OF OTHER NEARBY ANATOMIC STRUCTURES; SURGIFOAM® SPONGE SHOULD BE REMOVED FROM THE SITE OF APPLICATION WHEN USED IN, AROUND, OR IN PROXIMITY TO FORAMINA IN BONE, AREAS OF BONY CONFINE, THE SPINAL CORD, AND/OR THE OPTIC NERVE AND CHIASM. PRECAUTIONS: WHEN PLACED INTO CAVITIES OR CLOSED TISSUE SPACES, MINIMAL PRELIMINARY COMPRESSION IS ADVISED AND CARE SHOULD BE EXERCISED TO AVOID OVERPACKING (THE SPONGE EXPANDS UPON ABSORPTION OF LIQUID). SURGIFOAM® SPONGE MAY SWELL TO ITS ORIGINAL SIZE ON ABSORBING FLUIDS, CREATING THE POTENTIAL FOR NERVE DAMAGE; ONLY THE MINIMUM AMOUNT OF SURGIFOAM® SPONGE NEEDED TO ACHIEVE HEMOSTASIS SHOULD BE USED. ONCE HEMOSTASIS IS ACHIEVED ANY EXCESS SURGIFOAM® SPONGE SHOULD BE CAREFULLY REMOVED. INTERNALT REFERENCE NO.: (B)(4).

    Description of Event or Problem · 1

    EVENT DESCRIPTION AS REPORTED BY THE PATIENT TO THE DISTRIBUTER ((B)(4)): IT WAS REPORTED BY THE PATIENT DURING A CERVICAL THORACIC LAMINECTOMY THAT SURGIFOAM WAS USED. THE ADVERSE EVENT ACCORDING TO THE PATIENT WAS DISCOVERED POST-OPERATIVE. WHEN THE PATIENT WOKE UP AND EXPERIENCED NEUROLOGICAL PARALYSIS. THE PROCEDURE WAS ON (B)(6) 2018 AND WAS FOR A CERVICAL THORACIC LAMINECTOMY. SURGIFOAM WAS APPLIED TO THE SPINAL DURA AT TWO LOCATIONS, THE CERVICAL AND THORACIC. THE PROCEDURE WAS COMPLETED AND WHEN THE PATIENT CAME OUT OF THE ANESTHESIA HE FOUND THAT HE WAS PARALYZED. HE WAS TAKEN FROM THE SURGICAL CENTER WHERE THE OPERATION WAS PERFORMED TO AN IN-PATIENT ACUTE SPINAL CORD INJURY REHABILITATION CENTER. HE STAYED THERE FOR SEVERAL MONTHS. FROM THERE HE WAS TAKEN TO A SKILLED NURSING SPINAL CORD INJURY REHABILITATION CENTER. THE PATIENT DID NOT SPECIFY HOW LONG HE STAYED AT THAT FACILITY. FROM THERE HE WAS TAKEN TO A FACILITY FOR OUTPATIENT PHYSICAL THERAPY WHERE HE ENGAGED IN PHYSICAL THERAPY AND OCCUPATIONAL THERAPY FOR NEUROLOGICAL DEFECTS SEVERAL DAYS A WEEK. ACCORDING TO THE PATIENT HIS DOCTOR HAS NOT SAID TO MUCH ABOUT HIS CONDITION. HIS DOCTOR DEFINED THE PATIENT'S CONDITION AS TETRA PARESIS. THE PATIENT INDICATED THAT HE ORIGINALLY WENT IN FOR STENOSIS (LAMINECTOMY FOR STENOSIS OF THE CERVICAL AND THORACIC). IT IS UNKNOWN WHAT TYPE OF SURGIFOAM HAS BEEN USED (POWDER OR SPONGE AND WHICH SIZE) THE INFORMATION WAS RECEIVED ON 04.25.2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380088 SURGIFOAM SURGIFOAM LMF FERROSAN MEDICAL DEVICES A/S 1974 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization