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	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was conducted and confirmed that this device met manufacturing specification prior to shipping from rti surgical.Prior to the return of the complaint device, a unit from the same lot was pulled from rti surgical inventory for inspection purposes and was found to be conforming.The complaint device was later returned to rti surgical and passed quality assurance inspections.The patient confirmed to have fallen which is likely the cause of the device migration.A nonconformance could not be identified and the device was found to meet manufacturing specification.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 implant migrated post-operatively.

• 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: 8895077
• Report Number: 1833824-2019-00028
• Device Sequence Number: 285973
• 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: 06/26/2018
• Device Model Number: 65-TS-13-26-6L
• Device Catalogue Number: SAME
• Device Lot Number: 318492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR