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

Model Number	P8.5-80D305
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.At this time, the alleged event could not be confirmed.
Event or Problem Description
Information was received that alleged after two weeks out the precice nail has only achieved 3mm of length.It is unknown if the nail is distracting.Although requested, there was no patient information provided.
Additional Manufacturer Narrative
The device was received for evaluation and the reported issue was confirmed.Visual inspection of the nail showed minor visible scratches on the upper portion of the nail.X-ray images of the internal components of the nail revealed a flattened anti-jam washer.Functionality testing revealed that the nail was not distracting.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• 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: 8950492
• Report Number: 3006179046-2019-00150
• Device Sequence Number: 11478057
• Product Code: HSB
• UDI-Device Identifier: 00812258022440
• UDI-Public: 812258022440
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K170169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P8.5-80D305
• Device Catalogue Number: P8.5-80D305
• Device Lot Number: A160406-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: Other