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

Model Number	P8.5-50M165
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received a removal surgery took several hours and all 3 nails broke and multiple bones fractured.The patient needs to be in a wheelchair for 6 weeks and all the fractures were treated conservatively.Complaint 3 of 3.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The device was not returned for evaluation as the customer refused the return.Review of the provided x-ray images were unable to confirm any broken bones or that the nail had disassembled.The provided images were not taken during or after the removal procedure, but during the overall distraction process.The reported event occurred during the removal process.A root cause of the reported event is unable to be determined.It is unknown if the difficult removal was the cause of the broken bones.Bone quality is unable to be assessed on plain images (especially fluoroscopic images) and it was not reported that the patient had poor bone quality.Device history review (dhr): a review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.Labeling review: general potential adverse events and complications: as this is a major surgical procedure, there are known complications associated with orthopedic surgery such as bone fractures, nonunion, delayed union, malunion, premature healing (consolidation), decrease in bone density due to stress shielding, inadequate screw fixation, difficulty with nail or screw removal, early or late infection that may result in the need for additional surgeries, damage to blood vessels or nerves, deep venous thrombosis or pulmonary emboli, acute local inflammatory response, loss of sensory and/or motor function or paralysis, pain, abnormal sensations, and/or permanent deformity.Cautions: device should be removed after implantation time of no more than one year.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Corrected section: d2- device product code.
Event or Problem Description
No additional information provided.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 19075608
• Report Number: 3006179046-2024-00126
• Device Sequence Number: 20004280
• Product Code: HSB
• UDI-Device Identifier: 00812258028213
• UDI-Public: 812258028213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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: P8.5-50M165
• Device Lot Number: 8052502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 06/18/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/18/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 80 KG