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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE STRUT, SMALL, 08MM
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ZIMMER SPINE STRUT, SMALL, 08MM Back to Search Results
Model Number 1804-108
Device Problems Bent (1059); Fitting Problem (2183)
Patient Problem No Code Available (3191)
Event Date 07/11/2014
Event Type  malfunction  
Event Description
Same case as: 2184052-2014-00129, 2184052-2014-00127, 2184052-2014-00128.It was reported the implant would not lock properly during surgery.When advancing the struts into the endplate, the struts "scissored" at the anterior end of the endplate.The surgeon was unable to lock the implant.The parts were removed from the patient and the case was completed with a competitor product.
 
Manufacturer Narrative
Additional relevant information will be provided when the device evaluation is completed.
 
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Brand Name
STRUT, SMALL, 08MM
Type of Device
STRUT, SMALL, 08MM
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake rd.
minneapolis MN 55439
Manufacturer Contact
scott lapointe
7375 bush lake rd.
minneapolis, MN 55439
9528325600
MDR Report Key4219060
MDR Text Key22266659
Report Number2184052-2014-00130
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/11/2014
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
Device Operator Health Professional
Device Model Number1804-108
Device Catalogue Number1804-108
Device Lot Number57KT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/15/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/11/2014
Initial Date FDA Received08/07/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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