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

Model Number	BT10-90SJ340-5
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.No x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.Warnings: patients treated with precice bone transport may need secondary surgery to ensure union at the distal docking site.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2021 in order to place a new transport screw and perform a new osteotomy.It was also reported that there was a fracture of the bone transport at the docking site segment due to poor bone quality.

• 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: 11336194
• Report Number: 3006179046-2021-00124
• Device Sequence Number: 19959009
• Product Code: HSB
• UDI-Device Identifier: 00887517979797
• UDI-Public: 887517979797
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: BT10-90SJ340-5
• Device Lot Number: 9111116AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/16/2021
• 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: 35 YR
• Patient Weight: 90