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

Model Number	PS10.0-50D235
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of device history record for the nail confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release.A supplemental report will be submitted with device evaluation findings.
Event or Problem Description
It was reported that during the explant procedure after successful limb lengthening, the nail was found to have corrosion at the telescoping junction and abnormal bone was seen in the same area upon explant.No patient impact has been noted at this time and the surgeon will continue to monitor and evaluate the patient.
Additional Manufacturer Narrative
Visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration.This issue is currently being investigated through the capa process.
Event or Problem Description
No additional information has been provided.

• 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: 11589362
• Report Number: 3006179046-2021-00212
• Device Sequence Number: 3546996
• Product Code: HSB
• UDI-Device Identifier: 00887517951168
• UDI-Public: 887517951168
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Expiration Date: 06/30/2022
• Device Model Number: PS10.0-50D235
• Device Lot Number: 0070708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 68