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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. FACILITY ACQUA IMPL TI 2.9X10; ENDOSSEOUS DENTAL IMPLANT
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JJGC S.A. FACILITY ACQUA IMPL TI 2.9X10; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 140.737
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/25/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patienor procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.
 
Event or Problem Description
The clinician reports that the day the implant was placed in fdi 35, failure occurred upon insertion.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
FACILITY ACQUA IMPL TI 2.9X10
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key11932168
Report Number3008261720-2021-03587
Device Sequence Number4491283
Product Code DZE
UDI-Device Identifier07899878017035
UDI-Public07899878017035
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K150199
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/03/2021
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 Date03/13/2020
Device Model Number140.737
Device Catalogue Number140.737
Device Lot Number133404
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2021
Event Location Other
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/03/2021
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 Required Intervention;
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