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

Model Number MC2-4570S

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Failure of Implant (1924); Low Oxygen Saturation (2477); Blood Loss (2597)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.

Event Description

Information was received that during fluoroscopy it was observed that the end cap was disengaged from the rod.As per reporter, a revision procedure is planned.

Event Description

Received information stating the revision procedure was extended due to surgical complications.Patient was taken to the intensive care unit (icu) instead of general ward.

Manufacturer Narrative

Even though no product has been returned, fsca investigation was performed and variation in the torque applied to the threaded cap during the assembly process was identified as the root cause of the failure.Per the manufacturing instructions, the threaded cap must be tightened to 40 in-lbs.Although all operators followed the assembly procedure, and the torque wrench indicated 40 in-lbs was applied, the manner of using the torque wrench resulted in variances in applied torque.The manner in which the operator handles the torque wrench may impact the actual torque applied to the end cap, thereby creating a false positive that the specified torque has been applied.If the specified torque is not applied, the effectiveness of the cap tightening process may be compromised.

Event Description

Additional information provided: d4, h6, h7 h9, 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; suite 100; aliso viejo CA 92656
• MDR Report Key: 9246070
• MDR Text Key: 167994760
• Report Number: 3006179046-2019-00168
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4570S
• Device Catalogue Number: PA0684-007
• Device Lot Number: 8061809
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1898-2020
• Patient Sequence Number: 1
• Treatment: STRYKER XIA SCREW SYSTEM.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 7 YR