MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TAS NANOLOCK SURFACE TECHNOLOGY; 12 DEG LORDOTIC, IMPLANT, STANDARD, 12MM

Model Number 2312-0112-N

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

The endoskeleton® tas bone screw, 2300-5530 (v13) is jammed through the endoskeleton® tas implant's cage window, 2312-0112-n (tm0008001).The bone screw is unable to be separated from implant with use of normal instrumentation.The bone screw has damaged threading which likely resulted from the bone screw incorrectly being inserted through the implant's cage window.The bone screw's hex has damage and appears to be stripped.This damaged could have been caused by the screw being incorrectly forced into position or while attempting to back the screw out.The implant has damage at the bone screw insertion holes and the implant's cage window.The implant has been deformed in these areas reasonably caused by a bone screw being forced into an incorrect position.Images of the corresponding damaged and jammed tas bone screw and implant are attached.Endoskeleton® tas surgical technique provides instructions for the proper placement of bone screws with tas implants.X-rays should be used to confirm the desired trajectories of the bone screws.If surgeon used x-rays to confirm the trajectory of bone screw in this case, surgeon would have been able to identify the incorrect trajectory of the bone screw prior to driving the screw into the jammed position within the implant.A review of the products device history record was performed for subject devices.The review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would contribute to this complaint condition.The device was found to be within specification during inspection.

Event Description

During a scoli deformity correction the surgeon was doing an alif l4/l5 procedure, somehow drove the screw through the back of the implant and were not able to back the screw out.Surgeon attempted to back out the cage with the screw in place.During the process something vascular was nicked, the vascular surgeon clamped the vessel and was able to stop the bleeding.Surgeon was able to put in another cage and complete the procedure.The vascular surgeon closed the patient and the surgery was completed.

Event Description

During a scoli deformity correction the surgeon was doing an alif l4/l5 procedure, somehow drove the screw through the back of the implant and were not able to back the screw out.Surgeon attempted to back out the cage with the screw in place.During the process something vascular was nicked, the vascular surgeon clamped the vessel and was able to stop the bleeding.Surgeon was able to put in another cage and complete the procedure.The vascular surgeon closed the patient and the surgery was completed.

Manufacturer Narrative

The endoskeleton® tas bone screw, 2300-5530 (v13) is jammed through the endoskeleton® tas implant's cage window, 2312-0112-n (tm0008001).The bone screw is unable to be separated from implant with use of normal instrumentation.The bone screw has damaged threading which likely resulted from the bone screw incorrectly being inserted through the implant's cage window.The bone screw's hex has damage and appears to be stripped.This damaged could have been caused by the screw being incorrectly forced into position or while attempting to back the screw out.The implant has damage at the bone screw insertion holes and the implant's cage window.The implant has been deformed in these areas reasonably caused by a bone screw being forced into an incorrect position.Images of the corresponding damaged and jammed tas bone screw and implant are attached.Endoskeleton® tas surgical technique provides instructions for the proper placement of bone screws with tas implants.X-rays should be used to confirm the desired trajectories of the bone screws.If surgeon used x-rays to confirm the trajectory of bone screw in this case, surgeon would have been able to identify the incorrect trajectory of the bone screw prior to driving the screw into the jammed position within the implant.A review of the products device history record was performed for subject devices.The review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would contribute to this complaint condition.The device was found to be within specification during inspection.-.

• Brand Name: ENDOSKELETON® TAS NANOLOCK SURFACE TECHNOLOGY
• Type of Device: 12 DEG LORDOTIC, IMPLANT, STANDARD, 12MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6358609
• MDR Text Key: 68356247
• Report Number: 3006340236-2017-00002
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: M68223120112N0
• UDI-Public: +M68223120112N0/$$3210105TM0008001/16D201607070
• Combination Product (y/n): N
• PMA/PMN Number: K141953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/05/2021
• Device Model Number: 2312-0112-N
• Device Catalogue Number: 2312-0112-N
• Device Lot Number: TM0008001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention