MAUDE Adverse Event Report: ZIMMER SPINE UNIVERSAL CLAMP GENERIC

Model Number SN2027 UNIVERSAL

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Neck Pain (2433)

Event Type  Injury  

Event Description

It was report via legal allegations that on (b)(6) 2011, the pt underwent surgery in which universal clamp instrumentation was implanted; other instrumentation was implanted as well.Post-operatively the pt began experiencing disabling neck pain and headaches persisting for over two years.Revision surgery was performed in (b)(6) 2013.

• Brand Name: UNIVERSAL CLAMP GENERIC
• Type of Device: UNIVERSAL CLAMP GENERIC
• Manufacturer (Section D): ZIMMER SPINE; cite mondiale; 23 parvis des chartrons; bordeaux 3308 0; FR 33080
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd; edina, MN 55439 ; 9528575636
• MDR Report Key: 4024003
• MDR Text Key: 4845616
• Report Number: 3003853072-2014-00009
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN2027 UNIVERSAL
• Device Catalogue Number: SN2027 UNIVERSAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention