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

Model Number PS11.5-80SJ265

Device Problems Material Discolored (1170); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); 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 lengthening process was completed and consolidation was underway, however, there is a periprosthetic fracture at the tip of the nail and there is evidence of osteolytic changes around the telescopic part of the nail.The patient has lost 12mm of length.No patient injury was reported.

Event Description

No additional information was provided.

Manufacturer Narrative

Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.Device evaluation: the returned precice stryde nail was visually evaluated and no damage was found.X-ray images of the internal components showed no damage and revealed the nail was partially distracted.The nail was functionally tested and was able to distract and retract within specifications with the electronic remote controller and high-speed magnet.Distraction force testing was measured and also found to meet specification.The root cause of the reported event was unable to be determined as the nail met the specifications.

• 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: 11369898
• MDR Text Key: 233272182
• Report Number: 3006179046-2021-00145
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951670
• UDI-Public: 887517951670
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80SJ265
• Device Lot Number: 0020716AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 100