BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 14577881 · Received June 2, 2022

    Report

    Report Number
    2939274-2022-02038
    Event Type
    Injury
    Date Received
    June 2, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. EVENT DATE IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SPINE SCREW/ROD CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) FROM CARILION CLINIC. A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS PER IDENTIFIER HAVE BEEN IDENTIFIED AS FOLLOWS IN THE INITIAL REPORT: ID 2: A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID 3: A 45-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID 4: A 50-YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID 5: A 51-YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF SOME TINGLING IN THE LEFT ARM THAT IS MOD AND INTERMITTENT NECK PAIN; CHRONIC AND MODERATE LEFT SHOULDER PAIN THAT IS INTERMITTENT; STILL EXPERIENCING NECK PAIN. ID 9: A 76-YEAR-OLD PATIENT (BMI = 25.5) EXPERIENCED PAIN IN BOTH SHOULDERS; PAIN SWALLOWING. ID 10: A 43-YEAR-OLD PATIENT (BMI = 28.8) EXPERIENCED CERVICAL PAIN AND SHOULDER PAIN AFTER INITIAL IMPROVEMENT; NECK PAIN, LEFT TO RIGHT PAIN RADIATING TO WRIST. ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25) EXPERIENCED POSTOP DELIRIUM PRIOR TO DISCHARGE; RETURN OF BACK PAIN AND JERKING OF LEG/ FEET. ID 13: A 75-YEAR-OLD PATIENT (BMI = 35) EXPERIENCED DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; NECK PAIN DUE TO FALL; NECK PAIN; WORSENING NECK PAIN; CONTINUED NECK PAIN. ID 18: A 55-YEAR-OLD PATIENT (BMI = 42) EXPERIENCED DIFFICULTY SWALLOWING AT 6 WEEKS POSTOP. ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5) HAD SYNCOPE EPISODE PRIOR TO DISCHARGE. ID 21: A 55-YEAR-OLD PATIENT (BMI = 31.7) CONTINUES TO HAVE RIGHT NECK AND SHOULDER, PULLING PAIN/PRESSURE; WHEN GETS BAD PAIN GOES TO THE LEFT SHOULDER; PAIN 7-8/10. ID 25: A 45-YEAR-OLD PATIENT (BMI = 38.36) HAD DIFFICULTY SWALLOWING AT 6 WEEKS POSTOP; HAD CONTINUED NECK AND RIGHT ARM PAIN. ID 24: A 44-YEAR-OLD PATIENT (BMI = 33.1) HAD DIFFICULTY SWALLOWING AT 6 WEEKS POSTOP; NECK AND RIGHT ARM PAIN; CERVICAL PAIN WITH RIGHT ARM PAIN THAT IS CHRONIC AND SEVERE. ID 31: A 57-YEAR-OLD PATIENT (BMI = 27.1) HAD MODERATE NECK STIFFNESS AT 3 MONTHS POSTOP. ID 33: A 65-YEAR-OLD PATIENT (BMI = 22.96) HAD AN ED ADMISSION FOR TRACHEOTOMY, PEG PLACEMENT, HEMATOMA IN NECK EXPLORATION AND EVACUATION ON (B)(6) 2018; HAD LOWER CERVICAL PAIN AT 3 MONTHS POSTOP; CERVICAL PAIN AND LEFT ARM PAIN THAT IS CHRONIC AT 6 MONTHS POSTOP. ID 34: A 42-YEAR-OLD PATIENT (BMI = 40) HAD AN ED VISIT ON (B)(6) 2018 BECAUSE PATIENT FELL BACKWARD AND HIT BACK OF HEAD, CERVICAL PAIN AND RIGHT ARM PAIN; NECK PAIN AND NERVE INJURY AT 3 MONTHS POSTOP; NECK PAIN, NERVE DAMAGE, PAIN RADIATING DOWN LEFT ARM WITH NUMBNESS AND TINGLING. ID 35: A 54-YEAR-OLD PATIENT (BMI = 41.5) HAD NECK PAIN POST SURGICAL FLARE UP; PATIENT FELL IN TUB 3-9-17 AND HIT HEAD/NECK. ID 37: A 48-YEAR-OLD PATIENT (BMI = 28.1) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE. ID 40: A 37-YEAR-OLD PATIENT (BMI = 30.3) HAD DIFFICULTY SWALLOWING AT 6 WEEKS POSTOP. ID 41: A 66-YEAR-OLD PATIENT (BMI = 28.18) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 6 WEEKS POSTOP HAD LEFT ARM PAIN AT 2 WEEKS FOLLOW UP, RESOLVING. ID 43: A 52-YEAR-OLD PATIENT (BMI = 37.6) HAD PAIN AND DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; HAD CERVICAL PAIN WITH RADIATING PAIN DOWN RIGHT ARM. ID 44: A 48-YEAR-OLD PATIENT (BMI = 32.3) HAD ANTERIOR NECK HEMATOMA EVACUATION. ID 45: A 39-YEAR-OLD PATIENT (BMI = 33.08) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 6 WEEKS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING, NECK PAIN, ARM TINGLING; AT 3 MONTHS POSTOP HAD CONTINUED NECK PAIN AND RIGHT SHOULDER PAIN; AT 6 MONTHS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING, NECK PAIN, ARM TINGLING. ID 47: A 41-YEAR-OLD PATIENT (BMI = 27.36) HAD DIFFICULTY SWALLOWING AT 6 WEEKS POSTOP WHICH CONTINUED TO 12 MONTHS POSTOP. ID 52: A 46-YEAR-OLD PATIENT (BMI = 39.9) HAD PAIN AND DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 3 MONTHS POSTOP HAD CERVICAL STIFFNESS. ID 49: A 63-YEAR-OLD PATIENT (BMI = 31.22) HAD PAIN AND DIFFICULTY SWALLOWING PRIOR TO DISCHARGE WHICH CONTINUED UP TO 6 WEEKS POSTOP; NECK PAIN WAS ALSO NOTED AT 6 WEEKS POSTOP; AT 3 MONTHS POSTOP HAD CONTINUED NECK PAIN, DIFFICULTY SWALLOWING; AT 6 MONTHS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING, NECK PAIN, RIGHT ARM WEAKNESS, PAIN; AT 12 MONTHS POSTOP HAD CONTINUED NECK AND RIGHT ARM WEAKNESS. ID 53: A 43-YEAR-OLD PATIENT (BMI = 22.37) HAD DEBILITATING NECK AND ARM PAIN; UNDERWENT CERVICAL DECOMPRESSION. ID 54: A 43-YEAR-OLD PATIENT (BMI = 31.2) HAD INCISION PAIN AT 6 WEEKS POSTOP; AT 3 MONTHS POSTOP STILL SOME ANTERIOR SURGICAL SITE PAIN; EXPERIENCED DEBILITATING NECK PAIN; UNDERWENT REVISION SURGERY (REVISION PLATING SCREWS). ID 55: A 57-YEAR-OLD PATIENT (BMI = 28.1) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE. ID 56: A 56-YEAR-OLD PATIENT (BMI = 33.4) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 6 WEEKS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING. ID 58: A 64-YEAR-OLD PATIENT (BMI = 58.46) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 6 WEEKS POSTOP HAD PREVIOUS TROUBLE SWALLOWING, PAIN IN BOTH SHOULDERS. ID 59: IN A 53-YEAR-OLD PATIENT (BMI = 31.46), CHRONIC AND SEVERE CERVICAL PAIN SURGERY HAS IMPROVED AT 6 WEEKS POSTOP; AT 3 MONTHS POSTOP CERVICAL PAIN AND ARM PAIN HAVE IMPROVED. ID 61: A 47-YEAR-OLD PATIENT (BMI = 34.62) HAD FALL BACK IN (B)(6); CONTINUED NECK AND SHOULDER PAIN, TINGLING/ NUMBNESS IN ARMS AT 12 MONTHS POSTOP. ID 63: A 49-YEAR-OLD PATIENT (BMI = 22.5) HAD NECK PAIN, STIFFNESS, DIFFICULTY SWALLOWING, CHEST PAIN PRIOR TO DISCHARGE; AT 3 MONTHS POSTOP HAD CONTINUED NECK PAIN, SHOULDER PAIN; AT 6 MONTHS POSTOP HAD CHRONIC RIGHT SHOULDER PAIN; AT 12 MONTHS POSTOP HAD CERVICAL PAIN AND BURNING STINGING PAIN IN ALL EXTREMITIES. ID 65: A 50-YEAR-OLD PATIENT (BMI = 23.1) HAD NECK PAIN AND DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 6 WEEKS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING, NECK PAIN. ID 66: A 43-YEAR-OLD PATIENT (BMI = 37.2) HAD SHOULDER PAIN AT 6 WEEKS POSTOP; AT 6 MONTHS POSTOP HAD CONTINUED WORSENING NECK PAIN; AT 12 MONTHS POSTOP HAD CERVICAL AND LEFT SIDE PAIN. ID 67: A 38-YEAR-OLD PATIENT (BMI = 31.19) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE; AT 3 MONTHS POSTOP HAD CONTINUED NECK PAIN, SHOULDER PAIN; AT 12 MONTHS POSTOP HAD SIGNIFICANT AMOUNT OF NECK AND BACK PAIN. POSTERIOR NECK PAIN THAT RADIATES INTO HIS SHOULDERS. DOWN BACK OF BOTH ARMS, WORSE ON THE RIGHT SIDE; NUMBNESS IN BOTH HANDS. ID 69: A 65-YEAR-OLD PATIENT (BMI = 32.44) HAD DIFFICULTY SWALLOWING PRIOR TO DISCHARGE. ID 70: A 71-YEAR-OLD PATIENT (BMI = 38.36) HAD INTRAOPERATIVE SAGITTAL MIDLINE NON-DISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY; AT 6 WEEKS POSTOP HAD CONTINUED RIGHT ARM TINGLING; AT 3 MONTHS POSTOP HAD CONTINUED RIGHT ARM TINGLING AND INTERMITTENT PAIN. ID 74: A 55-YEAR-OLD PATIENT (BMI = 34.7) HAD DIFFICULTY SWALLOWING LARGE PILLS OR MEAT AND NECK STIFFNESS AT 3 MONTHS POSTOP; AT 6 MONTHS POSTOP HAD CONTINUED DIFFICULTY SWALLOWING, NECK STIFFNESS, SORENESS; AT 12 MONTHS POSTOP HAD POSTERIOR NECK SPASMS. ID 77: A 45-YEAR-OLD PATIENT (BMI = 53.11) HAD CONSTANT ACHE POSTERIOR NECK, HEAD, AND SHOULDERS AT 3 MONTHS POSTOP. ID 78: A 73-YEAR-OLD PATIENT (BMI = 28.7) HAD NEW NECK PAIN DUE TO MVC IN PARKING LOT, NECK SNAPPED BACK AND PATIENT WAS SENT TO ED. THE FOLLOWING WERE REPORTED IN THE PATIENT IDENTIFICATION (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS, ID 70: A 71-YEAR-OLD PATIENT (BMI = 38.36). DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS, ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25). SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS, ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5). DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT RESOLVED BEFORE 3 MONTHS, 5 PATIENTS - THAT RESOLVED AFTER 3 MONTHS, 1 PATIENT - ONGOING, 1 PATIENT - UNKNOWN STATUS. NECK PAIN: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS, 1 PATIENT - THAT RESOLVED AFTER 3 MONTHS, 29 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS. NECK PAIN: DEVICE RELATED: 1 PATIENT - RESOLVED BEFORE 3 MONTHS. SHOULDER PAIN: PROCEDURE RELATED: 6 PATIENTS - RESOLVED BEFORE 3 MONTHS, 3 PATIENTS - RESOLVED AFTER 3 MONTHS, 5 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS. ARM PAIN: PROCEDURE RELATED: 4 PATIENTS - RESOLVED BEFORE 3 MONTHS, 1 PATIENT - RESOLVED AFTER 3 MONTHS, 3 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS. ARM PAIN: DEVICE RELATED: 1 PATIENT - RESOLVED BEFORE 3 MONTHS. RADICULOPATHY: PROCEDURE RELATED: 2 PATIENTS - RESOLVED AFTER 3 MONTHS, 12 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS. MUSCLE TIGHTNESS: PROCEDURE RELATED: 3 PATIENTS - RESOLVED BEFORE 3 MONTHS, 2 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS, ID 2: A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91). NERVE DAMAGE: PROCEDURE RELATED: 2 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS, ID 34: A 42-YEAR-OLD PATIENT (BMI = 40). PARESTHESIA: PROCEDURE RELATED: 2 PATIENTS - RESOLVED BEFORE 3 MONTHS, 1 PATIENT - RESOLVED AFTER 3 MONTHS, 2 PATIENTS - ONGOING, 1 PATIENT - UNKNOWN STATUS. BILATERAL HAND TWITCH: PROCEDURE RELATED: 1 PATIENT - RESOLVED BEFORE 3 MONTHS, 1 PATIENT - UNKNOWN, ID 2: A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91). UNDERWENT REOPERATIONS DUE TO: 2 PATIENTS - ANTERIOR NECK HEMATOMA EVACUATION, ID 44: A 48-YEAR-OLD PATIENT (BMI = 32.3). 1 PATIENT - SPINE IRRIGATION AND DEBRIDEMENT (HEMATOMA REMOVAL), ID 33: A 65-YEAR-OLD PATIENT (BMI = 22.96). 1 PATIENT - CERVICAL DECOMPRESSION (RELATED TO ADJACENT LEVEL DISEASE), ID 53: A 43-YEAR-OLD PATIENT (BMI = 22.37). UNDERWENT REVISION: REVISION PLATE/SCREW (RESOLVED AFTER SURGERY); VECTRA RELATED ID 54: A 43-YEAR-OLD PATIENT (BMI = 31.2). THIS IS REPORT 11 OF 14 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SCREW/ROD CONSTRUCT (45-YEAR-OLD - PAIN). THIS COMPLAINT IS LINKED TO (B)(4). 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
    2196926 UNK - SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention