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

Model Number PS10.0-80D305

Device Problem Corroded (1131)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, the nail was corroded.The patient experienced pain and osteolysis.No additional information is available.

Manufacturer Narrative

Literature citation: rolfing, jan duedal, et al (2021).Pain, osteolysis, and periosteal reaction are associated with the stryde limb lengthening nail: a nationwide cross-sectional study.Acta orthopaedica, volume 92.Web address to article: https://doi.Org/10.1080/17453674.2021.1903278.

Event Description

Additional information was received via review of literature that the patient also experienced bony hypertrophy.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11465498
• MDR Text Key: 239721313
• Report Number: 3006179046-2021-00195
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951205
• UDI-Public: 887517951205
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-80D305
• Device Lot Number: 0060205AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 58