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

Model Number	EAD-P4-010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-ray films provided to confirm the alleged event.\.Root cause is unknown at this time.
Event or Problem Description
Information was received that the unit was not lengthening.No patient injury was reported.
Additional Manufacturer Narrative
The product was received for functional and visual testing and the reported event was confirmed.Visual inspection revealed no external damage to the unit.It was determined that the operator did not correctly perform part 10.29 per (b)(4) to verify coupler engagement and/or the unit has experienced a hard shock.The root cause for reported failure is an operator error.The device history record was reviewed and no discrepancies were found related to this complaint.The unit was manufactured in accordance with 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: 10348651
• Report Number: 3006179046-2020-00363
• Device Sequence Number: 14204478
• Product Code: HSB
• UDI-Device Identifier: 00887517014979
• UDI-Public: 887517014979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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 Model Number: EAD-P4-010
• Device Lot Number: 0061003BAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1