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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received that the rod failed and required a revision surgery to replace with a new rod.No further adverse patient impact was reported and no injury or harm was reported in relation to the reported event.No further information is available.

Manufacturer Narrative

Additional data: upon further review, this report was found to be a duplicate of mfr #3006179046-2019-00128.Any additional information received related to this device will be reported under mfr # 3006179046-2019-00128.

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; 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
• MDR Report Key: 13139259
• MDR Text Key: 283321211
• Report Number: 3006179046-2022-00102
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• 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): Hospitalization
• Patient Sex: Prefer Not To Disclose