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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRMA+; PRIMA PLUS IMPLANT 6.0X11.5 MM
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PRMA+; PRIMA PLUS IMPLANT 6.0X11.5 MM Back to Search Results
Model Number 15747K
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/08/2019
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
Failure to osseointegrate.
 
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Brand Name
PRMA+
Common Device Name
PRIMA PLUS IMPLANT 6.0X11.5 MM
MDR Report Key12694270
Report Number3005990499-2021-10489
Device Sequence Number14379198
Product Code DZE
UDI-Device IdentifierD76815747K0
UDI-Public+D76815747K0/$$324022943833M
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
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) 10/25/2021
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 Date02/28/2024
Device Model Number15747K
Device Catalogue Number15747K
Device Lot Number43833
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2019
Initial Report FDA Received Date10/25/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured02/28/2019
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 Age64 YR
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