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

Model Number RA002-4545SLR

Device Problems Break (1069); Corroded (1131); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.Device x-rays taken during the evaluation revealed clear evidence of pin fracture.Additionally, it was reported that during surface damage grading there was some galling and corrosion observed around the telescopic rod.Upon disassembly of the rod, the pin fracture was confirmed and there was debris found in the construct within the pin housing.The reason for removal was reportedly due to the pin fracture.There was no adverse patient or user impact associated with this report.No additional information is available.

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by london implant retrieval centre (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.

• 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: 15695253
• MDR Text Key: 304881461
• Report Number: 3006179046-2022-00265
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• 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
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SLR
• Device Lot Number: A150921-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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: 9 YR
• Patient Sex: Female
• Patient Weight: 24 KG