MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 8847150

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the radiograph confirms the reported event.There is no plan for a revision surgery at this time.No further evaluation of the product can be completed at this time.The root cause of this reported event has not been determined.Labeling review notes the following: "potential risks identified with the use of this device system, which may require additional surgery include: device component fracture, bending or loosening of implant, loss of fixation, fracture, fracture of the vertebra".Warnings, cautions and precautions: "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.It may be necessary for the surgeon to add length to the rod, depending upon the patient anatomy and desired lordosis".Device remains in-situ.

Event Description

On (b)(6) 2016, a (b)(6) year old male underwent 4-level interbody fusion l2-s1 with bilateral posterior pedicle screw instrumentation.Around 3 months postoperative, it was noted a rod reportedly migrated and multiple lock screws seem to be loose.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: kim mccaleb ; 7475 lusk blvd; san diego, CA 92121 ; 8589091980
• MDR Report Key: 5743256
• MDR Text Key: 47998131
• Report Number: 2031966-2016-00051
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517378309
• UDI-Public: 00887517378309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122352
• 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: 06/21/2016

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: 8847150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 40 YR