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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMA; PRIMACONNEX TAPERED SD 3.5X13
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PRIMA; PRIMACONNEX TAPERED SD 3.5X13 Back to Search Results
Model Number 15415K
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event 04/24/2019
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
PRIMA
Common Device Name
PRIMACONNEX TAPERED SD 3.5X13
MDR Report Key12694041
Report Number3005990499-2021-10430
Device Sequence Number13793918
Product Code DZE
UDI-Device IdentifierD76815415K0
UDI-Public+D76815415K0/$$3210331283434
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
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) 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 Date04/07/2021
Device Model Number15415K
Device Catalogue Number15415K
Device Lot Number28343
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2019
Initial Report FDA Received Date10/25/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/06/2016
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 Age67 YR
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