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

Model Number MS1-4570R

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 would not distract.No patient adverse event was reported.

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

The reporter provided the model and lot number of two magec rods, but it is unknown which of the two has the reported failure to distract.The two rods were reported as follows: ms1-4570r lot number a171016-03.Ms1-4570s lot number 0101446.

Event Description

Additional information was received.

Manufacturer Narrative

Corrected data: d4.Additional data: b5, d9, g3, g6, h2, h3, h4, h6, h10.Visual inspection of the returned magec rod revealed that the rod was partially distracted with some wear noted on the distraction rod.X-ray images of the internal components show no damage and revealed the rod has been partially distracted.The rod was functionally tested, and was able to distract and retract with the manual distractor as well as the external remote controller (erc).The length as received was measured at 208.96 mm.The minimum and maximum lengths were measured at 208.57 mm and 237.52 mm respectively; giving a total stroke measurement of 28.95 mm, which meet the specification.Distraction force testing was measured at 45.2lbs, which meets the 40lbs = force = 125lbs specification.The reported failure mode was unable to be confirmed, as the rod was fully functional and met acceptance test specifications.Review of the device history record for the rod confirmed that it met all of the required quality inspections.

Event Description

No additional information was 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: 14104349
• MDR Text Key: 290113062
• Report Number: 3006179046-2022-00167
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026349
• UDI-Public: 812258026349
• 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: MS1-4570R
• Device Lot Number: A171016-03-1AM
• 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: 10/16/2017
• 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