MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number RA002-4545SL70

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

An investigation report from an implant retrieval center was received and reported that during examination, the rod was not conform for force testing.Photos of the rod showed the rod was broken.It was reported that the rod was removed as part of a planned removal procedure after the rod had fully extended; there was no adverse patient or user impact associated with this report.No additional information is available.

Manufacturer Narrative

The device has not been returned for evaluation.The evaluation was performed by the london implant retrieval center (lirc).The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.Report 1 of 2.

Manufacturer Narrative

Additional data: b5, h10 the device was not returned to nuvasive for evaluation, however, the provided images of the removed rod were reviewed and confirmed that the rod was broken at the solid section.Without the return of the device, the root cause is unable to be determined.

Event Description

No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 17035212
• MDR Text Key: 316717990
• Report Number: 3006179046-2023-00257
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002244
• UDI-Public: 856719002244
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL70
• Device Lot Number: A160323-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2016
• 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 Age: 2 YR
• Patient Sex: Female