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

Model Number	PS10.0-50SJ235
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the london implant retrieval centre (lirc); no product was returned to the manufacturer for investigation.All precice stryde devices have been recalled since (b)(6) 2021 and are currently off the market.A capa was completed to address the reported event of corrosion.The capa found the risk management (rm) process was inadequate.Future rm files for all iterations of the device will be integrated from the nuvasive specialized orthopedics-specific risk management and design control process/procedures into the nuvasive, inc.Global risk management process/procedure.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.
Event or Problem Description
An investigation report from an implant retrieval center was received, detailing the examination of the retrieved implant.During the assessment, it was noted that the implant was able to be distracted and retracted and passed the force testing.Additionally, surface damage grading revealed notable corrosion, scratching, galling, surface deposits and discoloration.The report indicated that the rod was removed as part of a planned procedure following the achievement of the desired lengthening.The patient had previously reported experiencing mid-thigh pain.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19911892
• Report Number: 3006179046-2024-00155
• Device Sequence Number: 21020798
• Product Code: HSB
• UDI-Device Identifier: 00887517951595
• UDI-Public: 887517951595
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS10.0-50SJ235
• Device Lot Number: 0011725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 65 KG