MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number P8.5-80D305

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  Injury  

Event Description

It was reported that allegedly the precice nail was not lengthening.The physician revised the precice nail with a new nail without incident.

Manufacturer Narrative

A visual inspection of the returned precice nail was observed to be undamaged.An inspection of the x-ray images of the internal components revealed a damaged anti-jam washer.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• MDR Report Key: 8461148
• MDR Text Key: 140202879
• Report Number: 3006179046-2019-00030
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K141023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P8.5-80D305
• Device Catalogue Number: P8.5-80D305
• Device Lot Number: 6040602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR