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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information was received that the patient underwent a revision procedure due to the contralateral side rod failing to distract and migrating into the bones of the spine.The patient was found to have heterotopic ossification, decreased lung function by 10%, a deteriorating spine and a more prominent rib hump.Per the patient's mother the patient's spine was resected in order to explant the rod and a "wedge shape of bone was resected down to the spinal cord" and was left open.Additionally, upon explant, the patient was found to have metallosis and blackened tissue.

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.The reporter was unable to determine which rod corresponds to this report.The following model and lot numbers were provided: ra002-5555slr, a160531-03; ra002-5555sl, a160620-03.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.

Manufacturer Narrative

The unit was not returned to nuvasive for investigation.During evaluation of the provided x-ray images it was noted that the rod has been distracted just beyond the midpoint.The rod appeared to be slightly bent approximately 10 degrees.There were no additional obvious device-related abnormalities noted.From the x-ray review it does not appear that the rod has migrated into the bones of the spine as reported.There was no objective evidence provided for the reported heterotopic ossification or metallosis.The exact root cause of the reported failure could not be determined due to no device return and the reported failure was unable to be confirmed.The inspection data for the lot of the distraction rod and the housing tube was reviewed and confirmed that the parts met design specifications per the engineering drawings.

Event Description

No additional information has been provided.

• Brand Name: MAGEC 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: 15059076
• MDR Text Key: 296211081
• Report Number: 3006179046-2022-00230
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K161751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Sex: Male