MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH PEDICLE HOOK; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179752000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh.Complainant part is not expected to be returned for manufacturer review/investigation.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.
Event or Problem Description
It was reported that on (b)(6) 2019, patient underwent t2-t12 instrumented fusion for idiopathic scoliosis.The following screws, rods and hooks were placed: left side: t2 laminar 8mm wide blade hook, t3 4.35 x 35 verse, t4 5.0 x 35 verse, t5 skip, t6 5.0 x 40 verse, t7 skip, t8 5.0 x 40 verse, t9 5.0 x 40 verse, t10 5.0 x 40 verse, t11 6.0 x 40 and t12 6.0 x 40.Right side: t2 pedicle up going hook expedium, t3 skip, t4 pedicle up going hook expedium, t5 4.35 x 35 verse, t6 skip, t7 5.0 x 35 verse, t8 skip, t9 6.0 x 40 verse, t10 skip, t11 6.0 x 40 verse and t12 6.0 x 40 verse.Two 5.5 x 480 cocr rods were cut and placed with correction keys and regular locking caps for hooks.Correction keys were locked on the concave side to create mono screws on the left side.Upon removing the right side, the patient lost ssep¿s (somatosensory evoked potential) and motors to lower extremities.All the rods were removed.Signals did not come back.Wake up test performed and slight movement of lower extremity but marginal.Images were taken to confirm accurate screw placement and all screws locked well placed.All screws were removed, and pedicles were stimulated with a probe.No responses were seen in any pedicles to stimulation.They began to close and wake up the patient.Lower extremities tested with prick test upon awakening.No sensations below upper quad areas bilaterally.Patient being transferred for mri imaging to assess an ischemic event.Patient was closed after osteotomies and removal of instrumentation leaving the outcome incomplete barring sensory loss of both ssep¿s and motors in lower extremities.Implants were removed and patient was woken up to assess issue and prevent further potential issues.Sensation was minimal at that time to prick testing.The procedure outcome was incomplete.The patient hasn¿t seen much positive improvement in sensory ability.As of (b)(6) 2019, the patient was getting tingling in lower extremities.This report is for a pedicle hook.This is report 8 of 10 for (b)(4).Additional reports are captured in (b)(4).

• Brand Name: PEDICLE HOOK
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9311557
• Report Number: 1526439-2019-52399
• Device Sequence Number: 11271713
• Product Code: NKB
• UDI-Device Identifier: 10705034076805
• UDI-Public: (01)10705034076805
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 179752000
• Device Catalogue Number: 179752000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 47