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

Model Number	8845500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, patient's bone quality is unknown.It is unknown if the patient followed post-operative instruction or suffered a fall.Radiograph review confirmed left side rod fracture at l5, right side rod fracture at s1, tulip separation at s1 (noted immediately after index surgery), anterior positioning of the l4-l5 interbody implant, posterior positioning of l5-s1 interbody implant as well as 5mm superior subsidence into l5 vertebra.Anterior osteophytes are also present at l2-s1 levels.In addition to these noted observations the interfixated spacers at l2, l3, and l4 were not nuvasive products; only one of two provided fixation screw points "superior screw holes" were utilized.The root cause of this reported event appears to be related to challenging anatomical features combined with procedural errors and resulted in suboptimal placement of interbody spacers at l4-l5, l5-s1 along with questionable bone quality and the acknowledgement of the tulip separation at s1 during placement.The decision to leave the tulip separation unresolved may have contributed due to unbalanced load stress, thus impacting the longevity of the construct.The surgeon reported substantial fusion had occurred; however, this could not be verified from films received.No revision has been completed or planned.The patient will continue to be monitored.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), loss of fixation, nonunion or delayed union." ".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." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." ".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)." device left in patient.
Event or Problem Description
On (b)(6) 2014 a (b)(6) male underwent a t10-to-iliac posterior fixation procedure.On (b)(6) 2015 radiographs showed left side rod fractured between l5-s1.No injury has been reported and no revision of the construct has occurred.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5644568
• Report Number: 2031966-2016-00036
• Device Sequence Number: 306445
• Product Code: NKB
• UDI-Device Identifier: 00887517375940
• UDI-Public: 00887517375940
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2016

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
• Operator of Device: Physician
• Device Model Number: 8845500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2016
• Initial Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107