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

Model Number UNKNOWN

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

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 rod is not lengthening and has migrated into the bones of the spine.Additionally, it was reported that the rod is surrounded by bone and will require bone to be cut.The patient's spine is deteriorating and their rib hump is becoming more prominent.

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

Event Description

Additional information was received that the patient's lung function decreased by 10% since the last test.The surgeon's anticipated course of action is to explant and replace with traditional growing rods.Explant procedure is planned, but has not been scheduled at this time.

Event Description

Additional information has been provided.

Manufacturer Narrative

The unit was not returned to nuvasive for investigation, however, during evaluation of the provided x-ray images it was noted that the rod has been distracted just beyond the midpoint.The rod appears to be slightly bent approximately 10 degrees.There were no obvious device-related abnormalities noted.Based on the x-rays provided, it does not appear the rod has migrated into the bones of the spine as reported and heterotopic ossification does not appear to be present to a significant extent.No device lot number was made available despite attempts to obtain; therefore, the device history record could not be reviewed.Possible causes of the reported failure could not be determined due to no device return, unavailability of lot information, and no device-related abnormalities noted in the review of the x-ray images.Should the device be received for analysis, this investigation will be updated.

Event Description

No additional information has been provided.

Manufacturer Narrative

The reporter was unable to determine which rod corresponds to this report, however, the following model and lot numbers were provided: ra002-5555slr, a160531-03.Ra002-5555sl, a160620-03.There was no objective evidence provided for the reported heterotopic ossification or metallosis.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 engineering drawings.Device records review: review of the device history records for both provided lots indicated that the unit met all quality specifications and testing prior to product departure.

Event Description

Additional information was received that the patient was found to have heterotopic ossification.The rod has been explanted at this time.The patient's spine had to be resected in order for the rod to be explanted.A "wedge shape of bone was resected down to the spinal cord" and it was left open.Upon explant the patient was found to have metallosis and blackened tissue.

• 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: 13690446
• MDR Text Key: 286747173
• Report Number: 3006179046-2022-00137
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K171791
• 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,Followup,Followup
• Report Date: 08/08/2022

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
• 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
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 03/09/2022; 05/23/2022; 07/13/2022
• Supplement Dates FDA Received: 03/11/2022; 03/19/2022; 06/06/2022; 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male