MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number RA002-5555SL

Device Problems Break (1069); Corroded (1131); Detachment of Device or Device Component (2907); 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 would not distract and force testing was unable to be performed.Additionally, it was noted during surface damage grading that there was corrosion.Upon disassembly of the rod, clear evidence of a locking pin fracture; this was also confirmed with high energy x-ray evaluation.The telescopic rod and internal screw were found separated at retrieval.It was reported that the rod was removed due to a locking pin fracture.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.If any additional information is provided, a supplemental report will be submitted.Report 1 of 2.

Manufacturer Narrative

The device was not returned to nuvasive for evaluation, however, the provided patient x-rays were reviewed and confirmed a locking pin failure and that the device had become detached.Without the return of the device, the root cause is unable to be determined.

Event Description

No additional information has been provided.

Manufacturer Narrative

A review of the device history record (dhr) confirmed the device met all required inspections and specifications prior to release.

Event Description

Additional information has been provided.

• Brand Name: MAGEC GENERATION 1 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: 17032334
• MDR Text Key: 316717461
• Report Number: 3006179046-2023-00241
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161751
• 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,Followup
• Report Date: 11/28/2023

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: RA002-5555SL
• Device Lot Number: A121001-05
• 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; 11/28/2023
• Supplement Dates FDA Received: 08/28/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Sex: Female