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

Model Number	RA002-5555SL
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history record (dhr) confirmed the device met all required quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that upon removal it was noted that the patient had developed metallosis which was debrided during the procedure.There were no complication due to the observed metallosis.No additional information has been provided.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the rod was returned to nuvasive for evaluation.Upon visual inspection of the rod, scoring marks on the distraction rod were observed which are generally associated with incremental distractions.The presence of black debris was observed between the surfaces of the distraction rod and the housing tube.In-house x-rays revealed that the distraction rod and lead screw were not concentric with respect to the housing body.In addition, the distraction rod appeared to be contacting the inner surface of the housing tube, which is a possible reason for the score marks on that side of the distraction rod.X-rays also discovered a broken radial bearing.The rod was then sectioned, and the o-ring was examined.The o-ring was found torn and the housing tube¿s grove was worn down from the distraction rod rubbing on the inner surface.It is possible that the presence of external bending forces on the rod could have led to the scoring and by extension the generation of metal debris.These external bending forces could have also caused the distraction rod to have unequal compression on the internal o-ring, which can result in a torn seal.A compromised seal can lead to a broken bearings as bodily fluids ingress into the internal mechanism, increasing the friction on the bearing.Due to the broken bearing, functional testing was not possible.No patient x-rays or blood work results were provided, therefore, the reported metallosis could not be confirmed.However, wear debris was confirmed visually as it was found on the device upon return.The black debris that was found is likely titanium debris caused by friction during use.
Additional Manufacturer Narrative
Corrected data: h6 (health effect - impact code and device code).
Event or Problem Description
No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: 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: 18070052
• Report Number: 3006179046-2023-00352
• Device Sequence Number: 7815044
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: 0071504AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 02/19/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/16/2024; 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose