MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH®; SCREW, FIXATION, BONE

Model Number	9001640
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a screws.It was reported that the four months after the operation for cerebral hemorrhage, the patient came to our hospital for cranioplasty.The surgery was performed on (b)(6) 2022.Ten screws were needed to fix the skull during the operation, but during the operation, it was found that three screws had soft heads and could not be embedded in the skill, which would could lead to instability of the skull.The screws were replaced and the issue was resolved.The injury was mainly caused by a cerebral hemorrhage problems with titanium screw was discovered during implantation in patient's skull.Soft referred to the tip of the titanium screw that did not drill well into the skull and was embedded in the skull.
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH®
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15658871
• Report Number: 2021898-2022-00197
• Device Sequence Number: 20442025
• Product Code: HWC
• UDI-Device Identifier: 00613994106810
• UDI-Public: 00613994106810
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 9001640
• Device Catalogue Number: 9001640
• Device Lot Number: T220280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2019
• 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
• Patient Age: 46 YR
• Patient Sex: Female