MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TAS STANDARD SCREW 6.5MM, 25MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2300-6525
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on (b)(6) 2018 as regulatory report.Per request, it is being resubmitted as an initial report.The dhr records were reviewed and indicated no anomalies or non-conformances were generated during manufacturing.The product was returned for evaluation.The major diameter was measured with a caliper across the affected threads and the diameter was found to be undersized as a result of the material removal.During installation the screw is placed through the implant until the tip of the screw makes contact with the endplate.When the screw is in this position the first two crests are inside the implant.The screw is subsequently rotated to insert further.The damage to the screw is likely not seen until the third crest because it occurred at the entry to the screw bore in a scenario where the screw threads made contact with the implant.It could not be determined which portion of the screw bore the threads made contact with.The screw made contact with the entrance to the bore because it was improperly positioned in relation to the implant.It could not be determined why the screw position was off.On (b)(6) 2018, titan spine was notified by the distributor that the patient had passed away on (b)(6) 2017, 2 days after the operation.The patient's death was unrelated to this event or any titan spine product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during a tas implant level 1 (l4/5) procedure, while inserting the second screw the surgeon noticed the thread was delaminating from the screw.The surgeon removed the entire screw as well as the delaminated thread from the patient.The procedure was still able to be completed on the patient without delay.At the time of reporting there were no reported or known adverse effects to the patient.

• Brand Name: ENDOSKELETON TAS STANDARD SCREW 6.5MM, 25MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7289855
• Report Number: 3006340236-2018-00001
• Device Sequence Number: 2804413
• Product Code: OVD
• UDI-Device Identifier: 00191375001867
• UDI-Public: 00191375001867
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2300-6525
• Device Catalogue Number: 2300-6525
• Device Lot Number: V10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown