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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAGE; 4.8X8 RBM WDS STAGE1 IMP 1.8 COL
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STAGE; 4.8X8 RBM WDS STAGE1 IMP 1.8 COL Back to Search Results
Model Number RSW4808-2K
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Osteopenia/ Osteoporosis (2651)
Date of Event 12/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is being submitted as part of capa (b)(4) which identified late reports as part of a remediation effort.This report was missed during the switch from alternative summary reporting to mandatory medical device reporting.
 
Event or Problem Description
Loss of osseointegration.
 
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Brand Name
STAGE
Common Device Name
4.8X8 RBM WDS STAGE1 IMP 1.8 COL
MDR Report Key12694316
Report Number3005990499-2021-10443
Device Sequence Number11689167
Product Code DZE
UDI-Device IdentifierD768RSW48082K0
UDI-Public+D768RSW48082K0/$$7MS07076C
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/18/2021
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 Expiration Date11/30/2018
Device Model NumberRSW4808-2K
Device Catalogue NumberRSW4808-2K
Device Lot NumberMS07076
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/30/2019
Initial Report FDA Received Date10/25/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/20/2013
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age66 YR
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