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

Model Number	PS11.5-80B280
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned for investigation.Root cause is unknown at this time.
Event or Problem Description
During an x-ray it was identified that the right leg was shorter than the left leg.Upon physicians recommendation, prescription was adjusted.It was identified the nail no longer was lengthening.Patient underwent a revision procedure on (b)(6) 2020.
Event or Problem Description
Correction to lot # in section d.4.
Additional Manufacturer Narrative
The precice stryde was received for functional and visual testing and the reported event was not confirmed.The returned precice stryde was observed and no damage was found.The root cause of the reported event was not identified.Review of the device history record for the nail confirmed that it met all of the required quality inspections.

• 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: 10222292
• Report Number: 3006179046-2020-00338
• Device Sequence Number: 10908806
• Product Code: HSB
• UDI-Device Identifier: 00887517950840
• UDI-Public: 887517950840
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: PS11.5-80B280
• Device Catalogue Number: PS NAIL A.F.P., 11.5X80X280MM
• Device Lot Number: 9091709AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: 33 YR