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

Model Number MS1-4570S

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

Information was received that the rod failed to distract.No patient adverse event was reported.

Manufacturer Narrative

The device has been returned and is pending device 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

No additional information was provided.

Manufacturer Narrative

Device evaluation: upon receipt of the returned product score marks consistent with incremental distraction on the distraction rod.The distraction rod was able to be lengthened by hand which indicated a broken locking pin.X-ray images of the internal components and sectioning the rod confirmed the locking pin was broken.Sectioning the rod additionally revealed corrosion around the looking pin.As a result of the locking pin breakage, there is nothing constraining the axial motion of the distraction rod within the housing tube; this is usually known as "pistoning" which confirmed the reported failure.The root cause is likely due to corrosion and bending stresses.A capa was completed in which a new pin was implemented with 65 percent improved strength and significantly improved corrosion resistance.Device history records (dhr) review revealed that this unit was built prior to the release of the new pin.Device records review: a review of the dhr confirmed the unit met all of the required quality inspections and specifications prior to release.

• 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: 13720996
• MDR Text Key: 286941891
• Report Number: 3006179046-2022-00146
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-4570S
• Device Lot Number: A150304-10-00-02U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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: 27 KG