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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KEYSTONE DENTAL INC RESTORE; 3.75X11.5 RD RBM SELFTAPPING IMP
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KEYSTONE DENTAL INC RESTORE; 3.75X11.5 RD RBM SELFTAPPING IMP Back to Search Results
Model Number RS3811K
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/01/2019
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.(b)(4).
 
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
RESTORE
Common Device Name
3.75X11.5 RD RBM SELFTAPPING IMP
Manufacturer (Section D)
KEYSTONE DENTAL INC
154 middlesex turnpike
burlington MA 01803
MDR Report Key9661946
Report Number3005990499-2020-15262
Device Sequence Number14282782
Product Code DZE
UDI-Device IdentifierD768RS3811K0
UDI-Public+D768RS3811K0/$$323033138985S
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/09/2020
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 NumberRS3811K
Device Catalogue NumberRS3811K
Device Lot Number38985
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2019
Initial Report FDA Received Date02/03/2020
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 Other; Required Intervention;
Patient Age59 YR
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