MAUDE Adverse Event Report: NUVASIVE, INC. MAS PLIF FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 7070000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Radiographs were not received to confirm the event.The explanted hardware was investigated and observed markings which are consistent with an incomplete assembly.No patient injury reported.Labeling review: ".Potential risks identified with the use of this device system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss fixation." ".Care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique).Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire.Confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.".

Event Description

On (b)(6) 2016 a (b)(6) y/o female patient underwent posterior fixation surgery from l5-s1 with no reported issues.During a follow up appointment a tulip separation was observed at l5.On (b)(6) 2017 a revision surgery was performed.No patient injury reported.

• Brand Name: MAS PLIF FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 6583657
• MDR Text Key: 75723559
• Report Number: 2031966-2017-00052
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517204028
• UDI-Public: 00887517204028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 7070000
• Device Lot Number: JP5709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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 Age: 21 YR