BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3981625 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12990
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR THE 5 SCREWS, PART AND LOT NUMBER UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN EXTENSION DEFORMITY OF THE BIG TOE AND PLANTAR-FLEXION OF FIRST METATARSAL AFTER UNDERGOING A RIGHT-SIDED LEPIDUS BUNIONECTOMY. THE IMPLANTED DEVICES WERE A SYNTHES CLOVER LEAF PLATE WITH 5 LOCKING SCREWS. PATIENT REPORTS THAT THE SURGEON PERFORMED A SURGERY DIFFERENT THAN THE ONE SHE CONSENTED TO AND THAT SHE SUSTAINED INJURY TO HER ENTIRE FOOT AND RIGHT KNEE; INCLUDING TENDONS, MUSCLES, SKIN, BONES AND JOINTS ASSOCIATED WITH HER RIGHT FOOT AND KNEE. PATIENT REPORTED IN SEVERE DISABLING PAIN AND HAVING EMOTIONAL STRESS. NO REPORTED PRODUCT PROBLEM. INFORMATION BELOW CONDENSED AND DEFINED AS NEEDED FROM SURGEONS REPORT: (B)(6) 2012- POST OPERATIVE X-RAYS TAKEN REPORTED FINDINGS /IMPRESSION: BUNIONECTOMY AND POSTOPERATIVE CHANGES WITH SURGICAL SCREW SEEN OVER FIRST TARSOMETATARSAL JOINT REGION. NO SIGNIFICANT SOFT TISSUE ABNORMALITY IS IDENTIFIED. (B)(6) 2012-ONE WEEK POSTOPERATIVE EXAM REPORTED: POST-OPERATIVE X-RAYS EXAMINED; POST-SURGICAL CHANGES NOTED. RIGHT FOOT - VASC: +2/4 PEDIS AND POSTERIOR TIBIAL PULSES. CAP REFILL BRISK TO ALL TOES, +MILD EDEMA LOCALIZED TO SURGICAL SITE. SUTURES WERE INTACT WITH NO SIGN OF DEHISCENCE. NO PURULENCE, VERY MILD ERTHEMA ABOUT 0.2CM PERI SURGICAL SITE. NEURO: SENSATIONS GROSSLY INTACT. DISPENSED CAM WALKER, PATIENT DECLINED NON-WEIGHT-BEARING (NWB) CAST BUT REMAINED NWB IN WALKER USING CRUTCHES OR WHEELCHAIR TO OFFLOAD. USE ICE, ELEVATED LOWER EXTREMITIES, LIMITED ACTIVITIES, CONTINUE WITH VICODIN PRN FOR PAIN, RX KEFLEX. (B)(6) 2012-OFFICE VISIT X-RAYS. (B)(6) 2012: POST-SURGICAL CHANGES NOTED. RIGHT FOOT - VASC: +2/4 PEDIS AND POSTERIOR TIBIAL PULSES. CAP REFILL BRISK TO ALL TOES. RESOLVED ERTHEMA TO THE INCISION SITE. STATUS POST SURGERY (PRIMARY ENCOUNTER DIAGNOSIS) 2 WEEK SP/ RIGHT FOOT MODIFIED LAPIDUS BUNIONECTOMY DOS (B)(6) 2012. POSTOPERATIVE TREATMENTS: EXERCISE¿S 3 TIMES A DAY, 10 REPS EACH. CAM WALKER BOOT, NWB IN CAM WALKER BOOT USING CRUTCHES OR WHEELCHAIR TO OFFLOAD. ICE, ELEVATED LOWER EXTREMITY AND LIMIT ACTIVITIES. CONTINUE VICODIN PRN; SOFT BUNION SPLINT DISPENSED. (B)(6) 2012 OFFICE VISIT X-RAYS. (B)(6) 2012: POST-SURGICAL CHANGES NOTED. HEALING FUSION NOTED. PATIENT REPORTS FOLLOWING TREATMENT AT 6 WEEK VISIT. RIGHT FOOT - VASC: +2/4 PEDIS AND POSTERIOR TIBIAL PULSES. CAP REFILL BRISK TO ALL TOES. RESOLVED ERTHEMA TO THE INCISION SITE. SUTURES REMOVED AND SKIN WELL COAPTED. POSTOPERATIVE TREATMENTS: EXERCISE¿S 3 TIMES A DAY, 10 REPS EACH. CAM WALKER BOOT, PATIENT TO REMAIN PARTIAL WEIGHT-BEARING (WB) IN CAM WALKER BOOT FOR 1 MORE WEEK, CAN TRANSITION TO A REGULAR SUPPORTIVE SHOE IN 1 WEEK. (B)(6) 2012 OFFICE VISIT X-RAYS. (B)(6) 2012: POST-SURGICAL CHANGES NOTED. HEALING FUSION NOTED. PATIENT RETURNED TO WORK IN REGULAR SHOES. COMPLAINING OF PAIN PLANTAR METATARSAL HEAD 1 AND 5 AND THAT THE HALLUX DOES NOT PURCHASE THE GROUND. CONTINUE EXERCISES. RECOMMENDED PHYSICAL THERAPY WHICH PATIENT DECLINED. MAY NEED TO TAKE PATIENT BACK TO SURGERY FOR EXTENSOR HALLUCIS LONGUS (EHL) LENGTHENING AND SCAR TISSUE REVISION. PATIENT WILL CONSIDER AND CALL BACK. X-RAYS (B)(6) 2012 RIGHT FOOT - HALLUX ABDUCTOVALGUS NOTED, IM: 13. VERY SMALL SESAMOIDS NOTED. PES PLANUS FOOT. (B)(6) 2014.CAM WALKER USING CRUTCHES OR WHEELCHAIR TO OFFLOAD. ICE, ELEVATED LOWER EXTREMITY AND LIMIT ACTIVITIES. CONTINUE VICODIN PRN; SOFT BUNION SPLINT DISPENSED. THIS REPORT IS FOR THE 5 SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457194 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention