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

Model Number	P10.7-80D335
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 5925268
• Report Number: 3006179046-2016-00031
• Device Sequence Number: 16380130
• Product Code: HSB
• UDI-Device Identifier: 00812258020675
• UDI-Public: (01)00812258020675(17)20180430(10)A16051205(11)20160516
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2016

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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2016
• Supplement Report FDA Received Date: 10/31/2016
• 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: Hospitalization
• Patient Age: 17 YR