MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. 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 Problems 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.The reported event has been addressed in the device labeling.

Event Description

Information was received via literature that the patient had disseminated cortical osteolyses only on the right side level with the nail¿s telescopic junction which was clearly atypical and potentially implant-related.Complete resolution of the osseous alterations was achieved.

Manufacturer Narrative

The lot number for the device is unknown.However, two potential lot numbers were provided: 0013119aaa (manufacture date of jan 31, 2020).0013123aaa (manufacture date of jan 31, 2020).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.

Event Description

N/a.

Event Description

Additional information was received that the patient had lytic osteolysis and that they reported pain during distraction and consolidation.

Manufacturer Narrative

Corrected data.

• 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: 11092364
• MDR Text Key: 224247603
• Report Number: 3006179046-2020-00532
• 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,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS10.0-80D265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 40