MAUDE Adverse Event Report: CAPTIVA SPINE SMARTLOX; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	CP30067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/25/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Captiva spine received a returned cervical plate on (b)(6) 2015 from a distributor.The distributor representative was contacted for further information regarding the returned device.The representative indicated that revision surgery was completed after it was identified that the hardware was pulling out of the bone in an x-ray.Captiva spine completed an investigation and determined that there were no signs of unusual wear or deterioration of the hardware.It is unclear as to why the construct was pulling out of the bone.There have been no additional reports regarding this incident.

• Brand Name: SMARTLOX
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): CAPTIVA SPINE; 967 n. alternate a1a; suite 1; jupiter FL 33477 3224
• MDR Report Key: 7095738
• Report Number: 3006082533-2017-00009
• Device Sequence Number: 1379246
• Product Code: KWQ
• UDI-Device Identifier: M739CP300670
• UDI-Public: +M739CP300670/$$701120218H
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: CP30067
• Device Catalogue Number: CP30067
• Device Lot Number: 01120218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2015
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention