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

Model Number P10.7-80B335

Device Problems Break (1069); Component or Accessory Incompatibility (2897)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in the patient.Therefore, it was not returned for evaluation.However, x-ray images were provided, and the nail appeared to have broken in the crown area.

Event Description

It was reported that allegedly the patient fell.A x-ray was done and it revealed loss of distraction of the precice nail.The physician has not plans to remove the nail at this time.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: karen jaffe ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9495446507
• MDR Report Key: 8375778
• MDR Text Key: 139196822
• Report Number: 3006179046-2019-00023
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P10.7-80B335
• Device Catalogue Number: P10.7-80B335
• Device Lot Number: A170223-06-0AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1