MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL FORTILINK-TS TETRAFUSE; TETRAFUSE 13X26MM, 6L

Model Number	65-TS-13-26-6L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An update from the rep was provided to rti surgical on (b)(6) 2019.The update confirmed that the patient fell again after the 1st revision surgery and as a result, the implant slipped into the spinal canal.The surgeon is performing a 2nd revision today ((b)(6) 2019).The surgeon confirmed that some type of trauma was what caused both migrations.The device was not returned to rti surgical for inspections.Rti surgical pulled one unit of the same lot (318492) from inventory for inspection purposes.The implant that was pulled passed all inspections and was found to be manufactured to specification.A dhr review was conducted and confirms that the device associated with this occurrence met manufacturing specification prior to shipping from rti surgical.Additional information will be added to this report should it become available at a later date.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2019 that a fortilink-ts cage migrated post-operatively.The patient reportedly felt a "pop" and returned to the surgeon to be evaluated where imaging confirmed subsidence of the cage had occurred.

• Brand Name: PIONEER SURGICAL FORTILINK-TS TETRAFUSE
• Common Device Name: TETRAFUSE 13X26MM, 6L
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 8895011
• Report Number: 1833824-2019-00026
• Device Sequence Number: 1401077
• Product Code: MAX
• UDI-Device Identifier: 00846468084127
• UDI-Public: (01)00846468084127(17)230626(10)318492
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: 65-TS-13-26-6L
• Device Catalogue Number: SAME
• Device Lot Number: 318492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR