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

Model Number	PS11.5-80D335
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device has not been returned for device evaluation.Root cause is unable to be determined.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, the nail was broken at the second screw hole from the top.The patient experienced pain.Minor signs of corrosion were noted on the screws and screw holes.No additional information is available.
Event or Problem Description
Additional information was received via review of literature that the patient also experienced delayed healing.
Additional 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11465478
• Report Number: 3006179046-2021-00194
• Device Sequence Number: 11809461
• Product Code: HSB
• UDI-Device Identifier: 00887517951281
• UDI-Public: 887517951281
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS11.5-80D335
• Device Lot Number: 9040111AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 28 YR
• Patient Weight: 85