BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T PAL PROTI

    MDR report key: 14305668 · Received May 6, 2022

    Report

    Report Number
    3012966183-2022-00015
    Event Type
    Injury
    Date Received
    May 6, 2022
    Report Date
    May 5, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INTERBODY FUSION DEVICES ARE USED IN INTERBODY FUSION AND ARE PLACED WITHIN THE INTERBODY SPACE BETWEEN THE VERTEBRAL BODIES TO BE FUSED. OUR INTERBODY FUSION DEVICES ARE INDICATED FOR USE WITH SUPPLEMENTAL FIXATION. THE PROTI T-PAL DEVICE THAT WAS FROM THIS STUDY IS "INTENDED FOR SUPPLEMENTAL FIXATION SYSTEMS CLEARED FOR USE IN THE THORACOLUMBAR SPINE." AS A QUOTE FROM OUR LABELING. THE EXPEDIUM VERSE IS THE SUPPLEMENTAL FIXATION SYSTEM CLEARED FOR USE IN THE THORACOLUMBAR SPINE THAT WAS USED WITH THESE PATIENTS. IT IS A PEDICLE SCREW FIXATION SYSTEM THAT HELPS TO STABILIZE THE FUSION AND IS OFTEN USED WITH INTERBODY FUSION DEVICES LIKE OUR PROTI T-PAL DEVICE. AS REPORTED NONE OF THESE COMPLICATIONS ARETHOUGHT TO BE DEVICE RELATED.

    Description of Event or Problem · 0

    PATIENT ADMITTED FOR SEPSIS 10 DAYS POST-OPERATIVELY. MRI SUGGESTED DEEP WOUND INFECTION WHICH REQUIRED RE-OPERATIVE AND WOUND EXPLORATION. WOUND EXPLORATION FOUND NO INFECTION. PATIENT HAD HISTORY OF DVT, WAS MORBIDLY OBESE AND HAD PRE-OP TREATMENT WITH VENA CAVA FILTER. PATIENT DEVELOPED EXTENSIVE CLOTTING DISTAL TO HIS FILTER CAUSING A CAVAL OCCLUSION. PATIENT DIED OF CARDIAC COLLAPSE 2 WEEKS AFTER SURGERY. 4 OUT OF 5 REPORTABLE EVENT FROM REPORTED THE REPORTED COMPLAINT: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) OF A TOTAL OF 50 PATIENTS (30 MALES AND 20 FEMALES) WITH AN AVERAGE AGE OF 61 YEARS TREATED BETWEEN SEPTEMBER 2019 AND AUGUST 2020 WITH THE DEPUY SYNTHES EXPEDIUM VERSE SYSTEM, THIS CONSTITUTED THE EXPEDIUM VERSE COHORT. THE AVERAGE LENGTH OF FOLLOW-UP WAS 11.3 MONTHS (0-24 MONTHS). A SUBSET OF 33 PATIENTS WERE IMPLANTED WITH THE DEPUY SYNTHES EXPEDIUM VERSE SYSTEM AND T-PAL PROTI SYSTEM (T-PAL PROTI COHORT). THE AVERAGE AGE OF THE T-PAL PROTI COHORT WAS 61 YEARS WITH 11 FEMALES AND 22 MALES. THE AVERAGE LENGTH OF POST-OPERATIVE FOLLOW-UP WAS 11.9 MONTHS. WITHIN THE EXPEDIUM VERSE COHORT, INTERBODY CAGES WAS USED. PATIENTS RECEIVED T-PAL PROTI (66%), CONDUIT TLIF (2%), FEMORAL RING ALLOGRAFT (FRA)(12%), AND NO INTERBODY CAGE (20%). COMPLICATIONS, REOPERATIONS, AND REVISION WERE DESCRIBED BELOW: 5 PATIENTS EXPERIENCED COMPLICATIONS RESULTING IN 6 OPERATIONS IN 4 PATIENTS: 2 OF THESE PATIENTS EXPERIENCED SUPRA-ADJACENT BREAKDOWN WITH STENOSIS REQUIRING EXTENSION OF THEIR PREVIOUS FUSION AT 12 AND 14 MONTHS AFTER THEIR INDEX SURGERY. 1 OF THESE PATIENTS DEVELOPED A DEEP VENOUS THROMBOSIS (DVT) AND PULMONARY EMBOLISM IN THE FIRST SIX WEEKS AFTER SURGERY. THE PATIENT WAS TREATED WITH ANTI-COAGULATION FOR 6 MONTHS AND OTHERWISE RECOVERED UNEVENTFULLY. NONE OF THESE COMPLICATIONS ARE THOUGHT TO BE DEVICE RELATED. 1 (MALE) OF THESE PATIENTS DEVELOPED A PSOAS ABSCESS THAT TRACKED ANTERIORLY TO HIS SPINE IMPLANTS AT 24 MONTHS POST-OPERATIVELY WHICH WAS TREATED WITH POSTERIOR IMPLANT REMOVAL AND WOUND VAC PLACEMENT WITH TWO SUBSEQUENT IRRIGATIONS AND CLOSURE. THE PSOAS ABSCESS WAS TREATED WITH ANTERIOR DRAIN PLACEMENT. THE INFECTION CLEARED WITHIN 6 WEEKS OF INTRAVENOUS ANTIBIOTICS AND WITH UNEVENTFUL WOUND HEALING. AT SUBSEQUENT SURGERY, THE FUSION MASS WAS OBSERVED TO BE SOLID. - 1 PATIENT WAS READMITTED FROM AN OUTSIDE HOSPITAL 10 DAYS POST-OPERATIVELY WITH SIGNS OF SEPSIS (HYPOTENSION, HYPOXIA, FEVER). AN MRI SUGGESTED A DEEP WOUND INFECTION WHICH REQUIRED REOPERATION WITH A WOUND EXPLORATION. NO INFECTION WAS FOUND IN THE WOUND. THIS PATIENT HAS A HISTORY OF DVT AND WAS MORBIDLY OBESE RESULTING IN PREOPERATIVE TREATMENT WITH A VENA CAVA FILTER. IT WAS FOUND THAT THE PATIENT HAD DEVELOPED EXTENSIVE CLOTTING DISTAL TO HIS FILTER CAUSING A CAVAL OCCLUSION. THE PATIENT DIED OF CARDIAC COLLAPSE TWO WEEKS AFTER SURGERY. THIS COMPLICATION WAS NOT DEVICE RELATED. ADDITIONALLY, THE FUSION STATUS OF THIS PATIENT WAS CONSIDERED TO BE NOT FUSED (TABLE 10). THIS IS FOR DEPUY SPINE EXPEDIUM VERSE PEDICLE SCREW SYSTEM AND T-PAL PROTI CAGE. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437921 T PAL PROTI SPACER MAX TYBER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other