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

Model Number PS10.0-50D235

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); Reaction (2414)

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 radiographic osseous alterations were observed and osteotomy related periosteal reaction was documented after a mean time period from procedure of 62.7±33.7 days (range 32-109) and a mean time period from end of distraction of 21.4±32.8 days (range -14-70).

Event Description

Additional information was received that the patient had lytic-hypertrophic osteolysis and the implant was found to have a corrosive stain.

Manufacturer Narrative

Corrected data: b2.Additional data: a2, a3, a4, b1, b5, b7, d8, h6.

Manufacturer Narrative

Additional data.

Event Description

N/a.

• 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: 11033926
• MDR Text Key: 222279828
• Report Number: 3006179046-2020-00509
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-50D235
• Device Catalogue Number: PS10.0-50D235
• Device Lot Number: 9050601AAA
• 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): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 55