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

Model Number RA002-4545SLR70

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.

Event Description

Information was received that the rod would not distract.No patient adverse event was reported.

Manufacturer Narrative

Complaint 1 of 2.Visual inspection of the returned magec rod revealed that the rod was partially distracted with some wear/score marks on the distraction rod consistent with expected markings due to incremental distraction.The wear/score marks observed on the distraction rod would indicate it was extended approximately 2-3 mm from its initial position.X-ray images of the internal components showed a broken radial ball bearing.The rod was functionally tested; during testing the rod was unable to distract or retract with the manual distractor as well as the external remote controller (erc).The rod was therefore determined to be jammed.Sectioning of the rod determined that the distraction rod could not be separated from the housing tube without the use of high force, which indicates the distraction rod was out of alignment.It is possible, bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to become wedged into the housing tube/become out of alignment, which may be a cause for the broken radial ball bearing.The rod was determined to be out of alignment possibly due to excessive axial loading.Additionally, it is possible that patient activities may be lined to the reported failure.Per the product eifu, contraindications include: "patients and/or families unwilling or incapable of following postoperative care instructions." review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.

Event Description

No additional information was provided.

Event Description

Additional information was received.

Manufacturer Narrative

Corrected data: d4.Additional data: b5, e1, g3, g6, h2, h6, h10.

• 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: 14104317
• MDR Text Key: 290112498
• Report Number: 3006179046-2022-00166
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002145
• UDI-Public: 856719002145
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SLR70
• Device Lot Number: 150810-04-1AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose