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

Model Number RA002-4545SLR

Device Problems Break (1069); Degraded (1153); Mechanical Problem (1384); Structural Problem (2506); Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by newcastle engineering lab.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.

Event Description

It was reported that when the rod was removed from the patient there was obvious pistoning/movement in the rod which may have been brought on by the use of force and the mallet.An investigation report from an implant retrieval center was received and reported that during examination of the rod, the retrieval center found the rod exerted no force during force testing.Additionally, the rod was unable to be further disassembled and the drive pin was unable to be examined.The o-ring was found to be damaged as it was noted to be thinner and it was deemed to be compromised.Due to the compromised sealing mechanism, debris was observed on the components.No additional information is available.

Event Description

No additional information has been provided.

Manufacturer Narrative

Updated section: h6- component codes and device code.

Manufacturer Narrative

Corrected section h6- device code.

Event Description

No additional information 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: 16358858
• MDR Text Key: 309568149
• Report Number: 3006179046-2023-00127
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: A131203-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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: 16 YR
• Patient Sex: Male