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

Model Number MC2-5590S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Information was received that a revision procedure occurred due to the end cap popping off and the rod no longer working.No patient injury has been reported.

Manufacturer Narrative

The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Device evaluation: visual inspection of the returned product confirmed the threaded cap was unthreaded from the housing tube and the reported failure mode was therefore confirmed.Further inspection showed the returned rod was partially distracted.The laser mark on the nail was confirmed.The issue recorded in this complaint is a previously reported event and had been further investigated as a corrective action was initiated.The root cause is due to variation in the cap tightening process; being unable to verify torque application.Device records review: review of the device history records (dhr) indicates the rod met all required quality inspections and specifications prior to product departure.In addition, the dhr indicates the device was manufactured prior to the latest updated design change.

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: 15055723
• MDR Text Key: 299007143
• Report Number: 3006179046-2022-00229
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022662
• UDI-Public: 812258022662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201543
• 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: 08/18/2022

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
• Device Operator: Health Professional
• Device Model Number: MC2-5590S
• Device Lot Number: 9032212AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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 Sex: Male
• Patient Weight: 47 KG