MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH STRAIGHT PLATE 1H X 1H 8 MM; PLATE, BONE

Model Number 015-042

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the surgery, the plate was broken and couldn't be used normally.The procedure was completed with backup product(s).The patient's status at the time of the report was alive-no injury.

• Brand Name: TIMESH STRAIGHT PLATE 1H X 1H 8 MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9788030
• MDR Text Key: 190669097
• Report Number: 2021898-2020-00077
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00643169620278
• UDI-Public: 00643169620278
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 015-042
• Device Catalogue Number: 015-042
• Device Lot Number: T214705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR