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

Model Number	BT115-10D400-7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact implant date was not known but occurred in the first half of 2020.The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a revision procedure was performed due to an infection which occurred during device latency/bone consolidation.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product showed minor scratches on the nail and it was partially distracted.X-ray images of internal components and functional testing did not apply due to the reported failure.As a part of the investigation the work order was reviewed and confirmed the device passed all inspections.Device records review: review of the device history records indicated that unit met all quality specifications prior to release.

• Brand Name: PRECICE BONE TRANSPORT 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: 11731736
• Report Number: 3006179046-2021-00262
• Device Sequence Number: 19791549
• Product Code: HSB
• UDI-Device Identifier: 00887517979445
• UDI-Public: 887517979445
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 07/14/2021

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: BT115-10D400-7
• Device Lot Number: 9121109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: Required Intervention