MAUDE Adverse Event Report: SPINAL ELEMENTS, INC MOSAIC; IMPLANT

Model Number 51412-207

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The device history record was evaluated and no deviations or discrepancies were observed.The device was not available for evaluation as it was not returned tot he manufacturer.

Event Description

Patient underwent an anterior cervical fusion procedure on (b)(6) 2013 with implants constructs at levels c3-c4 and c6-c7, above and a previous c4-c6 fusion.It was reported that approximately 3.5 years later the patient coughed and orally produced an intact implant construct.Thereafter, patient reportedly sought medical treatment elsewhere.No known related events have been reported.The device has not been returned for evaluation.

• Brand Name: MOSAIC
• Type of Device: IMPLANT
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer (Section G): SPINAL ELEMENTS INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: ms joy ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071840
• MDR Report Key: 7336775
• MDR Text Key: 102582806
• Report Number: 3004893332-2018-00003
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2018

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: 51412-207
• Device Lot Number: 120689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2018
• Device Age: 3 YR
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2013
• 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): Other