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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYSTONE DENTAL INC PRIMA; PRIMACONNEX STRAIGHT IMP WD 5.0X10
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KEYSTONE DENTAL INC PRIMA; PRIMACONNEX STRAIGHT IMP WD 5.0X10 Back to Search Results
Model Number 15435K
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This mdr was previously submitted to the fda by keystone dental.However, it was improperly submitted as a pdf file and we no longer have access to the webtrader account so we cannot confirm receipt by the fda.Therefore, out of an abundance of caution, we are resubmitting this mdr to the fda.[(b)(4)].
 
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
PRIMA
Common Device Name
PRIMACONNEX STRAIGHT IMP WD 5.0X10
Manufacturer (Section D)
KEYSTONE DENTAL INC
154 middlesex turnpike
burlington MA 01803
MDR Report Key9689364
Report Number3005990499-2020-15459
Device Sequence Number14308384
Product Code DZE
UDI-Device IdentifierD76815435K0
UDI-Public+D76815435K0/$$3221231376328
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/16/2020
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? No
Operator of Device Health Professional
Device Model Number15435K
Device Catalogue Number15435K
Device Lot Number37632
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/04/2019
Initial Report FDA Received Date02/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Congenital Anomaly; Other; Required Intervention;
Patient Age63 YR
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