MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	PS10.0-50SJ235
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Osteolysis (2377)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2020 due to localized pain in the distal tibia.X-rays were taken which showed osteolysis and osteomyelitis where the nail was telescoped.
Event or Problem Description
See updated information in h2, h3, h6 and h10.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Visual inspection revealed that the distraction rod has corrosion.The nail was sent to a third-party lab for examination if wear/corrosion.Per the implant retrieval analysis, "the implant was assessed to observe the amount of wear and corrosion on the components.There was clear evidence of corrosion at the telescopic junctions, indicative of mechanically assisted crevice corrosion.There was little evidence of adhesive or abrasive wear on the implant components.The results of the investigation demonstrated clear evidence of any corrosion product buildup (mild pitting/crevice/fretting corrosion) at the interface of the actuator and distraction rod.The moderate amount of corrosion damage to the implant was limited to the surface without substantial penetration into the bulk of the implant component and thus did not affect the structural integrity of either the actuator or distraction components." a review of the device history record (dhr) confirmed there were no deviations in the manufacturing process and that the finished product met all acceptance criteria.A capa was initiated to address the reported issue.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10632295
• Report Number: 3006179046-2020-00403
• Device Sequence Number: 1179157
• Product Code: HSB
• UDI-Device Identifier: 00887517951595
• UDI-Public: 887517951595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: PS10.0-50SJ235
• Device Lot Number: 9103001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 14 YR