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

Model Number	CDH8.5-50L210
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation, pictures provided confirm the alleged event.Root cause cannot be confirmed at this time.
Event or Problem Description
Information was received that a nail was removed as it was allegedly broken.No patient injury was reported.
Additional Manufacturer Narrative
The returned product's visual inspection confirmed the nail was broken at the third screw hole of the distraction rod.The root cause that the nail was broken was due to stresses generated by drilling prior to the free-hand drilling of the distal holes.The device history records were reviewed, and no discrepancies were found related to this complaint.The devices were manufactured per the specified requirements and met all of the required quality inspections.

• Brand Name: PRECICE 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: 10318238
• Report Number: 3006179046-2020-00352
• Device Sequence Number: 2979153
• Product Code: HSB
• UDI-Device Identifier: 00812258022761
• UDI-Public: 812258022761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/17/2020

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: CDH8.5-50L210
• Device Lot Number: A160422-07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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