MAUDE Adverse Event Report: ZIMMER SPINE UNIVERSAL CLAMP GENERIC

Model Number SN2027 UNIVERSAL CL

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Death (1802)

Event Type  Death  

Event Description

It was reported in a journal article that a pt had deceased 2 month post-operatively due to respiratory arrest.Unk if it was related to uclamp.

• 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; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4605207
• MDR Text Key: 5464744
• Report Number: 3003853072-2015-00006
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN2027 UNIVERSAL CL
• Device Catalogue Number: SN2027 UNIVERSAL CL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 11 YR