MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.633.280
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Additional procodes: mnh, mni, kwq, kwp.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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that, on (b)(6) 2019, the patient underwent a revision of a posterior spinal fusion surgery with the matrix system due to a fractured titanium (ti) hard precontoured rod.Originally, the patient had a posterior spinal fusion on an unknown date.On an unknown date after the implant surgery, the patient reported to the surgeon that she was still experiencing pain after the fusion had healed.Additional imaging was taken on an unknown date and was assessed that a (ti) rod had fractured on both sides just below the l5 screws.The original implants were removed from the pelvis and was revised to t10-s1 fusion.The surgery was completed with no adverse consequence to the patient.Concomitant devices reported: unknown pedicle screws (part# /lot# /quantity: unknown), unknown polyaxial screw head (part# /lot# /quantity: unknown), unknown transverse connector (part# /lot# /quantity: unknown), unknown locking cap (part# /lot# /quantity: unknown).This complaint involves two (2) devices.This report is for one (1) 5.5mm ti hard precontoured rod 80mm straight length/400mm.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h10: the rods were discarded during the case.Part number 04.633.280 x 2, the lot number are unavailable.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.

• Brand Name: 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9198729
• Report Number: 2939274-2019-61577
• Device Sequence Number: 16901840
• Product Code: NKB
• UDI-Device Identifier: 10705034746449
• UDI-Public: (01)10705034746449
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.633.280
• Device Catalogue Number: 04.633.280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/07/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: MATRIX.; UNKNOWN LOCKING CAP.; UNKNOWN PEDICLE SCREW.
• Outcome Attributed to Adverse Event: Required Intervention