MAUDE Adverse Event Report: OSSEUS FUSION SYSTEMS GEMINI-C CERVICAL INTERBODY DEVICE; CERVICAL CAGE

Catalog Number 2000-1613-06L

Device Problems Device Issue (2379); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Neck Pain (2433)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

While performing acdf procedure surgeon impacted driver to fully seat gemini-c implant into inter-vertebral cavity.During this impaction the implant deformed on the corner of anterior wall.The surgeon removed the implant and implanted another device.Again insertion resistance was experienced and a small crack was noticed on the corner of the implant.The surgeon elected to leave the implant in place.The surgery was completed with no further incidence.

Event Description

While performing acdf procedure surgeon impacted driver to fully seat cervical cage into inter-vertebral cavity.During the impaction the implant deformed on the corner of the anterior wall of the implant.Implant was removed and another was implanted.Again insertion resistance was experienced and a small crack was seen on the corner of the implant, however the surgeon elected to leave the implant in place.Surgery was completed without further incidence.

• Brand Name: GEMINI-C CERVICAL INTERBODY DEVICE
• Type of Device: CERVICAL CAGE
• Manufacturer (Section D): OSSEUS FUSION SYSTEMS; 2703 w. mockingbird ln.; dallas TX 75235
• Manufacturer (Section G): OSSEUS FUSION SYSTEMS; 2703 w. mockingbird ln.; dallas TX 75235
• Manufacturer Contact: jonathan rosen ; 2703 w. mockingbird ln.; dallas, TX 75235 ; 4074975263
• MDR Report Key: 7372467
• MDR Text Key: 103694705
• Report Number: 3010531060-2018-00001
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 2000-1613-06L
• Device Lot Number: 1543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: 70 YR