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

Model Number PS11.5-80SJ265

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Pain (1994); Non-union Bone Fracture (2369); Numbness (2415); Neuralgia (4413); Cramp(s) /Muscle Spasm(s) (4521); Increased Sensitivity (4538); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 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.

Manufacturer Narrative

Corrected data: d6a additional data: b5, b7, d6b, h6, h10.

Event 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
• Type of Device: 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
• MDR Text Key: 298982321
• Report Number: 3006179046-2022-00245
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951670
• UDI-Public: 887517951670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female