MAUDE Adverse Event Report: SEASPINE, INC REEF TA; TA1-928108 INTERBODY, 9MM X 28MM X 10MM, 8 DEG

Model Number	TA1-928108
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow ups have been performed in efforts to acquire further information on the condition of the patient and subsequent possible surgery.No information has been provided at the time of this report.Postoperative warnings: the patient should be advised that implants may bend, break, or loosen despite restriction in activity.Possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin.
Event or Problem Description
Physician had follow up visit with patient (b)(6) 2022, to review migration of reef ta cage.Cage was inserted from left sided approach, but has rotated 90 degrees and appears to be protruding 2mm beyond the border of the posterior disc space.Physician ordered a ct scan for the patient.There is no evidence of screw loosening.Expects patient will need revision, but will know more once ct images are available.At the time of this report, no ct scans have been received.

• Brand Name: REEF TA
• Common Device Name: TA1-928108 INTERBODY, 9MM X 28MM X 10MM, 8 DEG
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada drive; carlsbad, CA 92008 ; 7602165150
• MDR Report Key: 14291757
• Report Number: 3012120772-2022-00017
• Device Sequence Number: 5409263
• Product Code: MAX
• UDI-Device Identifier: 00889981124765
• UDI-Public: 00889981124765
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: TA1-928108
• Device Catalogue Number: TA1-928108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown