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

Model Number	BT10-10X400-7
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the bone transport nail was not transporting following implantation.No patient injury was reported.
Additional Manufacturer Narrative
Additional data: d8, d9, h3, h4, h6, h10.Correction: h1.Device records review: review of the device history records indicated that the unit was fully functional and met all quality specifications prior to release.Device evaluation: the nail was received disassembled, which prevented functional testing and x-ray analysis.Therefore, the failure mode could not be determined or confirmed.Attempts were made to contact the reporter to provide additional information and verify the reported failure; however, the reporter was unresponsive.If any relevant additional information is provided, a supplemental report will be submitted.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
Revised device evaluation: the patient¿s x-ray image was provided by the reporter and evaluated; the image confirms the nail did not transport bone.The root cause remains unable to be determined.
Event or Problem Description
No additional event information is available.

• 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: 11156976
• Report Number: 3006179046-2021-00106
• Device Sequence Number: 3501895
• Product Code: HSB
• UDI-Device Identifier: 00887517980724
• UDI-Public: 887517980724
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BT10-10X400-7
• Device Lot Number: 0090307AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 04/13/2021; 04/21/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 04/13/2021; 04/21/2021
• 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: 63 YR
• Patient Weight: 95