MAUDE Adverse Event Report: DIO MEDICAL DIO PLATE AND SCREWS

Device Problems Loose or Intermittent Connection (1371); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 09/23/2016

Event Type  Injury  

Event Description

Cervical spondylosis with radiculopathy and failure of previous hardware.Removal c3 through c6 anterior plate due to loosening of screws and protruding out of bone.

• Brand Name: DIO PLATE AND SCREWS
• Type of Device: DIO PLATE AND SCREWS
• Manufacturer (Section D): DIO MEDICAL; 1480 renaissance dr. ; ste 402; park ridge IL 60068
• MDR Report Key: 6010507
• MDR Text Key: 56972393
• Report Number: MW5065230
• Device Sequence Number: 1
• Product Code: MNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR