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

Model Number	P10.7-80C245
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, x-rays revealed there was no sign of lengthening.No patient injury was reported.
Additional Manufacturer Narrative
The nail was inspected and tested, and found to be unable to distract or retract (jammed).X-rays of the device found the internal anti-jam washer to be damaged.The external remote controller (erc) unit was reported to have been held in the incorrect orientation during lengthening sessions.Based on the reported information and investigation findings, the likely cause is the repeated retraction from improper use of the erc, which resulted in the mechanical jam.The device history records were reviewed, and no discrepancies were found related to this complaint.The devices were manufactured in accordance with the specified requirements and met all the required quality inspections prior to shipment.
Event or Problem Description
It was additionally reported that the patient's caregivers had been utilizing the external lengthening controller in the wrong direction (i.E.Shortening instead of lengthening).During the revision procedure, it was found the nail would no longer lengthen and it was removed and replaced with an external fixation.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11439897
• Report Number: 3006179046-2021-00170
• Device Sequence Number: 3497240
• Product Code: HSB
• UDI-Device Identifier: 00812258020453
• UDI-Public: 812258020453
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10.7-80C245
• Device Lot Number: 9071013AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNIDENTIFIED EXTERNAL REMOTE CONTROLLER.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 15 YR
• Patient Weight: 80