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

Model Number PS11.5-65B250

Device Problem Material Discolored (1170)

Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, the patient experienced a sudden increase in pain and bone abnormalities at the junction of the telescoping nail segments.Upon explant it was noticed that the nail was corroded.No patient injury was reported.

Event Description

Additional information was received via review of literature that the patient experienced swelling, osteolysis and periosteal reaction.

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.

• 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: 11439689
• MDR Text Key: 238874807
• Report Number: 3006179046-2021-00167
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517950826
• UDI-Public: 887517950826
• 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: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-65B250
• Device Lot Number: 9070217
• 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: 60