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

Model Number	PS10.0-80D265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Information was received via literature that the patient had localized cortical osteolysis only on the right side level with the nail¿s telescopic junction which is clearly atypical and potentially implant-related.Residual localized osteolysis was noticed at the last follow up.
Additional Manufacturer Narrative
The lot number for the device is unknown.However, two potential lot numbers were provided: 9051002aaa (manufacture date of may 10, 2019).9060802aaa (manufacture date of jun 8, 2019).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 or Problem Description
N/a.
Additional Manufacturer Narrative
Additional data: a4, b5, d8.Corrected data: b7.
Event or Problem Description
It was reported that the osteolysis was lytic only.

• 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: 11092351
• Report Number: 3006179046-2020-00531
• Device Sequence Number: 3739911
• Product Code: HSB
• UDI-Device Identifier: 00887517951182
• UDI-Public: 887517951182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS10.0-80D265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 07/23/2021; 08/23/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 08/09/2021; 09/09/2021
• 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: Other
• Patient Age: 17 YR
• Patient Weight: 63