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

Model Number	PS11.5-80SJ265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Numbness (2415); Neuralgia (4413); Cramp(s) /Muscle Spasm(s) (4521); Hyperresponsive to stimuli (4538); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail allegedly caused serious and severe injury to the patient.No additional information has been provided at this time.
Additional Manufacturer Narrative
Corrected data: d6a additional data: b5, b7, d6b, h6, h10.
Event or Problem Description
Information was received that the patient underwent a revision procedure to repair bone defect of the left tibia.The nail was replaced and bone morphogenetic protein was placed for the non-union the patient developed after lengthening 5cm.The patient also reportedly experienced constant numbness and increased sensitivity of the medial aspect of the left knee and mild left hip pain since implantation.The patient was treated with gabapentin for neuralgia and neuritis and reportedly had medial ecchymosis.Following the revision procedure, the patient reportedly presented with left fibular hemimelia, persistent bleeding of the incision site on the shin, soft tissue irritation, muscle spams, a dull aching sensation reported as pain when lengthening and over the osteotomy site, as well as deficits in lower extremity strength, range of motion, gait impairments and limitations.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15328063
• Report Number: 3006179046-2022-00245
• Device Sequence Number: 14774335
• Product Code: HSB
• UDI-Device Identifier: 00887517951670
• UDI-Public: 887517951670
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: PS11.5-80SJ265
• Device Lot Number: 9081311AAA
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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: Required Intervention
• Patient Sex: Female