MAUDE Adverse Event Report: TYBER MEDICAL 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 24MM

Model Number	04.333.224TS
Medical Device Problem Codes	Expulsion (2933); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
3mm cchs screw backed out(expulsion).This complaint involves one (1) device.
Event or Problem Description
3mm cchs screw backed out(expulsion).This complaint involves one (1) device.
Additional Manufacturer Narrative
A report was sent to the required agencies.The device was not returned for evaluation.There was no photographic evidence or radiography provided to evaluate the complaint event.(b)(4) devices were manufactured and released as they met all specifications.The expiration date for these devices is 5-5-2026.There were no capas or non-conformances associated with this lot number.A historical data review was conducted which showed only one complaint on record for this part.There are no capas related to this part.There are two non-conformances on record for this part number for unrelated issues.The current complaint rate for this device is (b)(4).Without further information, the device for evaluation, imaging, photographic evidence etc.The root cause cannot be established.

• Brand Name: 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 24MM
• Common Device Name: HEADLESS SCREW
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 17988448
• Report Number: 3012966183-2023-00020
• Device Sequence Number: 20902358
• Product Code: HWC
• UDI-Device Identifier: 00819917027488
• UDI-Public: 00819917027488
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Model Number: 04.333.224TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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