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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER DENTAL ANALOG IMP 5.7MM IMP 3MM HEX
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ZIMMER DENTAL ANALOG IMP 5.7MM IMP 3MM HEX Back to Search Results
Catalog Number IA5
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
 
Event Description
It was reported that upon opening of the package a fmt5 was found instead of the ordered ia5.
 
Event Description
No additional or corrected information to report.
 
Manufacturer Narrative
This report is submitted to relay corrected information.Previously report mfr-0002023141-2020-00203 has been submitted with incorrect information.The event was incorrectly reported as a serious injury.The event is in reality a non reportable malfunction.
 
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Brand Name
ANALOG IMP 5.7MM IMP 3MM HEX
Type of Device
ANALOG
Manufacturer (Section D)
ZIMMER DENTAL
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key9655804
MDR Text Key177984548
Report Number0002023141-2020-00203
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/31/2020
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 Catalogue NumberIA5
Device Lot Number2018120754
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/07/2020
Initial Date FDA Received01/31/2020
Supplement Dates Manufacturer Received03/12/2020
Supplement Dates FDA Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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