MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. CERVICAL MANAGEMENT BASE UNIT SWIVEL ADAPTER; HEAD/NECK PROCEDURE POSITIONER

Model Number	5979-323
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported some broken parts were epoxied back together, but broke again along the glue line.There was no injury.
Event or Problem Description
Customer reported some broken parts were epoxied back together, but broke again along the glue line.There was no injury.
Additional Manufacturer Narrative
Unable to establish root cause because the part was not returned.

• Brand Name: CERVICAL MANAGEMENT BASE UNIT SWIVEL ADAPTER
• Common Device Name: HEAD/NECK PROCEDURE POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9606609
• Report Number: 2921578-2020-00003
• Device Sequence Number: 524288
• Product Code: JEA
• UDI-Device Identifier: 00842430106101
• UDI-Public: 00842430106101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 5979-323
• Device Catalogue Number: 5979-323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1