MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. COUPLER II

Model Number 5873

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 10/04/2019

Event Type  malfunction  

Event Description

It was reported while trying to position an unstable cervical spine, the mayfield osi coupler assembly adapter failed to tighten.Patient had an injury/laceration as a result of the malfunction.

Event Description

It was reported while trying to position an unstable cervical spine, the mayfield osi coupler assembly adapter failed to tighten.Patient received a minor laceration.

Manufacturer Narrative

The equipment that was returned appeared to be in good condition.Testing showed that the device meets it specification; it locks in position and supports a load as expected.Unable to determine a reason why the users were unable to secure the device.No physical cause found.User error is suspected.

• Brand Name: COUPLER II
• Type of Device: COUPLER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9251713
• MDR Text Key: 164487074
• Report Number: 2921578-2019-00040
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: 00842430104534
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other