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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 015-246
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2024
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 cranial repair products.It was reported that when using the hand tools to tighten the screw during surgery, due to the lack of self-tapping properties of the screw, the doctor needed to use more force to tighten the screw causing the snowflake piece, connecting piece, and screw to deform and making it impossible to continue using it.It was noted that the hospital supply room collected damaged products from various manufacturers on a daily basis and provided them to the distributor at one time during the inventory period at the end of the year.It was asked for the doctors to use medtronic products of the same model instead.
 
Manufacturer Narrative
H3.Product analysis determined that the visual inspection confirmed the straight plate has been bent due to bend stress overload.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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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 Key18438469
MDR Text Key331881250
Report Number2021898-2024-00003
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00643169620452
UDI-Public00643169620452
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,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2024
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 Number015-246
Device Catalogue Number015-246
Device Lot NumberT251322
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/02/2024
Initial Date FDA Received01/03/2024
Supplement Dates Manufacturer Received05/08/2024
Supplement Dates FDA Received05/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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