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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER DENTAL; ZIMMER DENTAL SCREW
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ZIMMER DENTAL; ZIMMER DENTAL SCREW Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Device not returned.
 
Event Description
It was reported an unknown zimmer screw loosening, the crown was falling off.Screw was retightened.Tooth location 19.
 
Manufacturer Narrative
Additional information received, device investigation report identified the device as unknown biomet abutment screw.Upon reassessment of the reported event, it was determined that this device was filed under the incorrect manufacturing site, mfr number (0002023141-2020-02064) on 23 nov 2020.Therefore, this report is being filed under mfr# 0001038806-2021-00267.As a result, no further medwatch reports will be submitted.Please refer to mfr# 0001038806-2021-00267 for investigation and supplemental reports.
 
Event Description
No further event information available at the time of this report.Device was submitted under the incorrect manufacturing site.See h10 for details.
 
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Type of Device
ZIMMER DENTAL SCREW
Manufacturer (Section D)
ZIMMER DENTAL
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key10884890
MDR Text Key218663457
Report Number0002023141-2020-02064
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/12/2021
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 Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/23/2020
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
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