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

Model Number	RA002-5555SL70
Medical Device Problem Codes	Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned for evaluation; however device return is anticipated.No conclusions can be drawn at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the end cap was loose on the rod and liquid had escaped.No patient adverse event was reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of device evaluation.
Event or Problem Description
It was reported that while removing the rod after it had achieved lengthening goals, it was noted the rod had loose components and liquid had escaped.No patient adverse impact was reported.
Additional Manufacturer Narrative
Additional data: b5, d9, g3, g6, h2, h3, h6, h10.During visual inspection, score marks were observed on the rod, consistent with expected markings due to incremental distraction.Inspection of the returned rod revealed the distraction rod was functionally able to be lengthened by hand, which would indicate a broken locking pin.The reported failure mode is therefore confirmed, as distraction rod loose was able to be lengthened by hand.Because the locking pin is broken, there is nothing constraining the axial motion of the distraction rod within the housing tube.The pistoning action of the distraction rod due to a broken locking pin would allow for fluid ingress into the actuator.Liquid extrusion was also confirmed as the rod pistoned.In addition, sectioning the rod confirmed the broken locking pin.The patient's unique anatomy and/or daily activities are possible causes of the reported failure.The iqc inspection data for the lot of locking pin was reviewed, and the parts met design specifications per the engineering drawings.As part of the investigation, the work order was reviewed, and confirmed the device passed all inspections per the acceptance tests prior to shipment.
Event or Problem Description
No additional information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 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: 13528736
• Report Number: 3006179046-2022-00123
• Device Sequence Number: 4073273
• Product Code: PGN
• UDI-Device Identifier: 00856719002152
• UDI-Public: 856719002152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: RA002-5555SL70
• Device Lot Number: A16041103
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 03/04/2022; 03/29/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/01/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2016
• 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
• Patient Sex: Prefer Not To Disclose