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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTORE; 4.0X10 RD RBM SELFTAPPING IMP
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KEYSTONE DENTAL INC RESTORE; 4.0X10 RD RBM SELFTAPPING IMP Back to Search Results
Model Number RS4010K
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/11/2019
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.[complaint (b)(4)].
 
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
RESTORE
Common Device Name
4.0X10 RD RBM SELFTAPPING IMP
Manufacturer (Section D)
KEYSTONE DENTAL INC
154 middlesex turnpike
burlington MA 01803
MDR Report Key9689036
Report Number3005990499-2020-15454
Device Sequence Number3422857
Product Code DZE
UDI-Device IdentifierD768RS4010K0
UDI-Public+D768RS4010K0/$$3221031365525
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
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 NumberRS4010K
Device Catalogue NumberRS4010K
Device Lot Number36552
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 Age62 YR
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