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

Model Number	MC2-5570S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.It is unknown if patient complied with post-operative physical restrictions.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision surgery was performed.As per reporter, the rods stopped distracting after three elongations and a broken rod was observed.Reportedly, during the removal of the rod, the surgeon observed tissue debris around the rod.
Additional Manufacturer Narrative
Device evaluation: the rod was observed to have internal damage as it was able to distract and retract without any force applied due to a locking pin failure.The rod's locking mechanism was found to not be functioning as intended.The rod was unable to be distracted or retracted with the electronic remote controller (erc), manual distractor, or the fast distractor.X-rays of the internal components revealed the locking pin was damaged along the radial bearing.Sectioning of the rod revealed a broken locking pin and bearing.The lead screw was not able to spin freely.The reported failure mode was confirmed as the rod failed to distract.With the data provided, the patient's anatomical structure couple with their daily activities may have influenced the rod to experience excessive bending and wear.Therefore, the root cause may be due to excessive bending and wear.
Event or Problem Description
Updated report to include investigation findings.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9307227
• Report Number: 3006179046-2019-00174
• Device Sequence Number: 16687296
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC2-5570S
• Device Catalogue Number: PA0684-008
• Device Lot Number: A160411-03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR