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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY TIMESH®; PLATE, FIXATION, BONE Back to Search Results
Model Number 015-044
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a cranial repair plate.It was reported the surgeon was performing craniofacial surgery, and the device broke.The device was replaced with another one to complete the surgery.There was a procedure delay of 30 minutes.The patient's status at the time of the report was alive-no injury.
 
Manufacturer Narrative
H3.Product analysis determined that the visual and optical inspection confirmed one of the attached eyelets has broken.The damage appears to be from over tightening the plate screw.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
TIMESH®
Type of Device
PLATE, 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 Key18344459
MDR Text Key330719936
Report Number2021898-2023-00129
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00643169620292
UDI-Public00643169620292
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K973145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/19/2024
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
Device Operator Health Professional
Device Model Number015-044
Device Catalogue Number015-044
Device Lot NumberT256230
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received02/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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