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

Model Number P10.7-80D335

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient was implanted on (b)(6) 2016.The nail was removed on (b)(6) 2016 and the patient was implanted with a new nail without incident.To date, the patient is doing fine and no negative outcomes were reported.A preliminary evaluation from x-rays provided revealed that the internal components of the nail appear to have no damage to prevent the nail from distracting; the nail appeared to have lengthened.A dhr review revealed that the device met all of the required quality inspections, and was released within specifications.

Event Description

A distributor reported that a patient's precice nail was removed approximately three (3) weeks of implantation; the nail allegedly appeared to not be lengthening.

Manufacturer Narrative

A visual inspection of the returned device revealed that the nail was undamaged.X-ray images revealed no damage to the internal components.Functional testing of the precice nail revealed that the device was able to be distracted and retracted when tested with both a high speed magnet tool and an erc unit.The device operated within specifications and was fully functional; no malfunction was detected.A review of the lot history record revealed that the nail met all the required quality inspections and was 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 5925268
• MDR Text Key: 53838713
• Report Number: 3006179046-2016-00031
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020675
• UDI-Public: (01)00812258020675(17)20180430(10)A16051205(11)20160516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Model Number: P10.7-80D335
• Device Lot Number: A160512-05-0AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR