MAUDE Adverse Event Report: STRYKER OASYS CONNECTOR TRANSVERSE 60MM

Model Number 48551071

Device Problem Disconnection (1171)

Patient Problem Neck Pain (2433)

Event Date 12/06/2013

Event Type  Injury  

Event Description

Pt had device explanted after experiencing post.Neck pain.Pre-op x-rays showed disconnection of the connector between occiput and cervical rods.

• Brand Name: OASYS CONNECTOR TRANSVERSE 60MM
• Type of Device: CONNECTOR
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3757128
• MDR Text Key: 4418818
• Report Number: MW5035670
• Device Sequence Number: 2
• Product Code: KWP
• 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: 04/10/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48551071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 104