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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRA-LOCK INTRA-LOCK ABUTMENT

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INTRA-LOCK INTRA-LOCK ABUTMENT Back to Search Results
Model Number ABUTMENT
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This report summarizes one (1) malfunction event.A review of the event indicated that the reported abutment demonstrated a spinning abutment.The report was received from one source.No patient adverse event was reported.No information regarding the patient demographic was provided.
 
Event Description
This report summarizes 1 malfunction event.A review of the event involved a stripped abutment.No patient adverse events were reported.No information regarding patient demographics were provided.
 
Manufacturer Narrative
There are a total of 1 malfunctioned events with a stripped abutment.No product was returned for evaluation.Since, product was not returned for evaluation no conclusion may be drawn to the cause of the stripped abutment.A review of the device history record did not reveal any noted non-conformances.Hence, the devices were manufactured to specifications.Updated information the original file was sent on 10/29/2021 for 3rd quarter.
 
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Brand Name
INTRA-LOCK ABUTMENT
Type of Device
INTRA-LOCK ABUTMENT
Manufacturer (Section D)
INTRA-LOCK
2300 riverchase center
hoover AL 35244
Manufacturer (Section G)
INTRA-LOCK
2300 riverchase center
hoover AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
MDR Report Key12786517
MDR Text Key281517975
Report Number3003631996-2021-00334
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/29/2021
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 Health Professional
Device Model NumberABUTMENT
Device Catalogue NumberABUTMENT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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