MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	7094540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device returned for evaluation as it remains in-situ.The screw was confirmed fractured by radiograph but no root cause can be identified.Labeling review: "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)" "correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." remains in-situ.
Event or Problem Description
On (b)(6) 2017, a patient underwent a maximum access surgery posterior lumbar interbody fusion (mas plif) at l4-l5 levels.During a follow up appointment radiographs indicated the right screw at the l5 level fractured.No patient injury or revision procedure was reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6866552
• Report Number: 2031966-2017-00123
• Device Sequence Number: 124932
• Product Code: NKB
• UDI-Device Identifier: 00887517173966
• UDI-Public: 00887517173966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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
• Operator of Device: Physician
• Device Model Number: 7094540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR