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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER DENTAL; DRIVER TIP
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ZIMMER DENTAL; DRIVER TIP Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient information not provided/unknown.Event date not provided/unknown.Device brand name unknown.Device product code unknown.Device catalog and lot number not provided/unknown.
 
Event Description
It was reported that an unknown zimmer driver tip fractured off in the abutment screw (mhlas).The doctor was able to remove the fractured piece from the screw.No impact to the patient.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H6: entered evaluation codes.H10: added manufacturer narrative.
 
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Type of Device
DRIVER TIP
Manufacturer (Section D)
ZIMMER DENTAL
1900 aston avenue
carlsbad CA 92008
MDR Report Key8636245
MDR Text Key146630197
Report Number0002023141-2019-00225
Device Sequence Number1
Product Code DZA
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 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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