MAUDE Adverse Event Report: NUVASIVE, INC. SPHERX DEFORMITY SYSTEM; SPINAL PEDICLE SCREW SYSTEM

Model Number 8456540

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

In (b)(6) 2014 patient underwent l4-s1 fusion with tlif at l4/5 with bilateral pedicle screws and rod instrumentation.During routine 3 month follow up it was noted that both the s1 bone screws appeared to have fractured mid shaft.The patient returned (b)(6) 2015 for a tlif revision surgery at l5/s1 and replaced both bone screws.Patient activity level, bone quality, and compliance with post-surgical instructions are known.

Manufacturer Narrative

(b)(4).Radiographs received confirmed the event.Evaluation of the fractured surface of the bone screw suggests there was a cyclical fatigue failure.Review of the device history records notes no material non-conformances or manufacturing errors that may have cause or contributed to this mode of failure.Patient impact/sustained fall or other factors contributing to a failure are unknown.The root cause of this reported event has not been determined; no conclusion can be drawn.

• Brand Name: SPHERX DEFORMITY SYSTEM
• Type of Device: SPINAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: peter perhach ; 7475 lusk blvd.; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4532092
• MDR Text Key: 20125314
• Report Number: 2031966-2015-00002
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8456540
• Device Lot Number: NU3311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR