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

Model Number PS10.0-80D265

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

The device was not made available for evaluation.The root cause is unable to be determined.If any additional information is provided, a supplemental report will be submitted.Journal article citation: frommer, adrien, et al."focal osteolysis and corrosion at the junction of precice stryde intramedullary lengthening device." bone and joint research, vol.10, no.7, 16 july 2021.Https://online.Boneandjoint.Org.Uk/doi/epub/10.1302/2046-3758.107.Bjr-2021-0146.R1.Device not returned.

Event Description

Information was received via medical literature review that the patient had lytic-hypertrophic osteolysis at the nail¿s telescopic junction.No additional information is available.

Event Description

N/a.

Manufacturer Narrative

Correction: after further review, it was determined that this medwatch report is a duplicate of report#: 3006179046-2020-00531.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 12440928
• MDR Text Key: 270358211
• Report Number: 3006179046-2021-00454
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951182
• UDI-Public: 887517951182
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS10.0-80D265
• Device Lot Number: 9060802AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 63