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

Model Number	P8.5-80D245
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nail was removed and the patient was implanted with a new precice nail, without incident.The patient is continuing their lengthening treatment with precice, and no negative outcomes were reported.A dhr review revealed that there were no deviations from the manufacturing process, and that the device was released within specifications.
Event or Problem Description
A distributor reported that a patient's precice nail was removed after approximately one (1) month of implantation.The nail allegedly appeared to not be lengthening; however, the nail lengthened intra-operatively.

• 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: 5660020
• Report Number: 3006179046-2016-00014
• Device Sequence Number: 308699
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: (01)00812258020606(17)20180228(10)A160226-12(11)20160302
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2016

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: 03/01/2016
• Device Model Number: P8.5-80D245
• Device Lot Number: A160226-12-0AA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 08/10/2016
• 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: 9 YR
• Patient Weight: 45