MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART IMPLANT (3.3) 3.3X13 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.806
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was informed incorrectly.Therefore, it was disconsidered.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form.The original complaint was received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a follow-up report will be send.
Event or Problem Description
(b)(4) - the dentist reported that after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.The patient presented bone type ii.
Additional Manufacturer Narrative
After the evaluation was noticed that the item received is different from the item reported and does not have a 510k.Therefore, the item was corrected on the complaint file and the lot number was not considered.The item was not changed on the mdr, because the system will not allow it, only this information was inserted.
Event or Problem Description
1000402150: the dentist reported that after the dental implant was installed in patient¿s mouth, its non- osseointegration was observed.The patient presented bone type ii.

• Brand Name: TITAMAX SMART IMPLANT (3.3) 3.3X13 MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 8897941
• Report Number: 3008261720-2019-04044
• Device Sequence Number: 13532837
• Product Code: DZE
• UDI-Device Identifier: 07899878000150
• UDI-Public: 07899878000150
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K133510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019
• Report Date (Section F): 07/21/2019

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 Catalogue Number: 109.806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Other
• Date Report to Manufacturer: 07/21/2019
• Initial Date Received by Manufacturer: 07/21/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention