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

Model Number	PS10.0-65D250
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2021
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
Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, periosteal reaction occurred towards the distal tip and distal screw holes during the lengthening process.Metal on metal wear was evident on the nail.No patient injury was reported.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.Device evaluation: 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.

• 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: 11369910
• Report Number: 3006179046-2021-00147
• Device Sequence Number: 3865805
• Product Code: HSB
• UDI-Device Identifier: 00887517951175
• UDI-Public: 887517951175
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: PS10.0-65D250
• Device Lot Number: 0010941AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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