MAUDE Adverse Event Report: TYBER MEDICAL ACIS PROTI COM/L5 MM H; NTERBODY - ACIS

Model Number	108843505
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the historical data review and the device history record review there were no trends observed with this complaint type.There were no non-conformances or capas associated with the lot or part number.The surgical technique and device specifications were also reviewed for this investigation.Since the device was not returned and further information with regards to this case was not available at the time of this investigation the root cause is indeterminate.
Event or Problem Description
The surgeon implanted the cervical cage with the plunger from the acis set.The cage broke on the backside.Surgery was delayed due to the reported event for greater than 20 minutes., device was explanted and a replaced with a new device.Procedure was reported to be successfully completed., fragments were reported as being generated but easily removed without additional intervention.

• Brand Name: ACIS PROTI COM/L5 MM H
• Common Device Name: NTERBODY - ACIS
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 12066666
• Report Number: 3012966183-2021-00015
• Device Sequence Number: 17331540
• Product Code: ODP
• UDI-Device Identifier: 00819917020564
• UDI-Public: 00819917020564
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 06/25/2021

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 Expiration Date: 04/23/2024
• Device Model Number: 108843505
• Device Catalogue Number: 108843505
• Device Lot Number: 166116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/25/2021
• 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: Other