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

Model Number	PS11.5-80D280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.The reported event has been addressed in the labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the patient experienced pain and could only walk with the help of crutches and by taking analgesics.
Event or Problem Description
See updated information in h2, h3, h6 and h10.
Additional Manufacturer Narrative
Nail lot number 8092814aaa was returned for testing.Visual inspection of the nail revealed that that the nail was corroded and confirmed the reported issue.A device history review (dhr) was performed and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.This complaint failure mode is being internally investigated and results of the investigation are still pending.

• 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: 10956355
• Report Number: 3006179046-2020-00492
• Device Sequence Number: 583844
• Product Code: HSB
• UDI-Device Identifier: 00887517951267
• UDI-Public: 887517951267
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS11.5-80D280
• Device Lot Number: 8092814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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: 17 YR
• Patient Weight: 70