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

Model Number MC2-5070R

Device Problem Defective Device (2588)

Patient Problem Unspecified Infection (1930)

Event Date 07/13/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by lirc.No lab culture results were provided to confirm the reported event.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per the reporter, the rod was removed due to infection.

Manufacturer Narrative

Information was received that confirms that the initial report mfr # 3006179046-2020-00148, submitted on march 13, 2020, is a duplicate of mfr # 3006179046-2019-00175.Report mfr # 3006179046-2020-00148 is not needed.Any additional information for the reported event will be submitted under mfr # 3006179046-2019-00175.

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; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 9831128
• MDR Text Key: 188503101
• Report Number: 3006179046-2020-00148
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834010
• UDI-Public: 887517834010
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-5070R
• Device Lot Number: 7090903
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2017
• 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): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female