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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Z-SYSTEMS AG Z5; ENDOUSSEOUSDENTAL IMPLANT ROOT FORM
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Z-SYSTEMS AG Z5; ENDOUSSEOUSDENTAL IMPLANT ROOT FORM Back to Search Results
Model Number Z5M-36-12
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 09/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Biomechanical overload.
 
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Brand Name
Z5
Common Device Name
ENDOUSSEOUSDENTAL IMPLANT ROOT FORM
Manufacturer (Section D)
Z-SYSTEMS AG
werkhofstrasse 5
oensingen, 4702
SZ  4702
MDR Report Key10703193
Report Number3006948427-2020-02720
Device Sequence Number2875044
Product Code DZE
UDI-Device Identifier07640166760139
UDI-Public07640166760139
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K120793
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
Remedial Action Replace
Type of Report Initial
Report Date (Section B) 07/15/2020
Report Date (Section F) 02/12/2020
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 No Information
Device Expiration Date01/31/2024
Device Model NumberZ5M-36-12
Device Catalogue NumberZ5M-36-12
Device Lot Number17476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/12/2020
Device Age1 YR
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer02/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date10/20/2020
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; Disability;
Patient Age74 YR
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