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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT; CUSTOM CAST - MULTI-UNIT ABUTMENT
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BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT; CUSTOM CAST - MULTI-UNIT ABUTMENT Back to Search Results
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There was a total of four (4) malfunctioned units/events associated with engagement issues the reported abutment.A review of the device history record is performed for any reported event with a valid and confirmed lot number.No non-conformances were noted.Therefore, the conclusion of the device records review concluded the product was manufactured to specifications.1 of the 4 events did not have product returned for evaluation.Therefore, no conclusion can be drawn to nature of the reported event.2 of the 4 events are pending investigation.Product has been returned but no evaluated as of yet.Therefore, the conclusion is not yet available.1 of the 4 events had product returned.The evaluation of the product determined the engagement issue was caused by the end user resulting in a misuse.(b)(4).
 
Event Description
This report summarizes four (4) malfunction events.A review of the events involved abutments experiencing engagement issues.The report(s) were received from various sources.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.
 
Manufacturer Narrative
There was a total of four (4) malfunctioned units/events associated with engagement issues the reported abutment.A review of the device history record is performed for any reported event with a valid and confirmed lot number.No nonconformances were noted.Therefore, the conclusion of the device records review concluded the product was manufactured to specifications.1 of the 4 events did not have product returned for evaluation.Therefore, no conclusion can be drawn to nature of the reported event.2 of the 4 events are pending investigation.Product has been returned but no evaluated as of yet.Therefore, the conclusion is not yet available.1 of the 4 events had product returned.The evaluation of the product determined the engagement issue was caused by the end user resulting in a misuse.Health effect- impact code (h6): the health impact associated with the reported problem is rarely provided during the collection of information for the reported malfunction.Therefore, code 4648 is being used in h6 - health effect - impact code.Component code (h6): code 4756 within the component code section of h6 is being used because no other code within annex g is compatible with pro codes nha or ndp.Item number - pgmu1 ( udi: (b)(4)); pymu172 (qty 2) ( udi: (b)(4)).Unknown, item.
 
Event Description
This report summarizes four (4) malfunction events.A review of the events involved abutments experiencing engagement issues.The report(s) were received from various sources.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.
 
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Brand Name
BIOHORIZONS ABUTMENT
Type of Device
CUSTOM CAST - MULTI-UNIT ABUTMENT
Manufacturer (Section D)
BIOHORIZONS IMPLANT SYSTEMS
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS IMPLANT SYSTEMS
2300 riverchase center
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
MDR Report Key15136372
MDR Text Key297050714
Report Number1060818-2022-09397
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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