MAUDE Adverse Event Report: ZIMMER DENTAL EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH

Model Number	CT318
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
It was reported that implant fractured at tooth location # 13.Implant avulsed.Will replace.As a result of this event, no injury to the patient reported.Symptoms as a result of the event: none reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One eztetic dental implant (ct318) was returned for investigation.Visual evaluation of the as returned product identified no fracture.The device had minimal damages and bone residue around the external threads ¿ damage was possibly sustained during the removal process.Functional testing to recreate the reported event was not performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device had been placed on tooth # 13 (unknown notation system) for approximately 1 year.X-ray/picture evaluation: none provided by the customer.Appropriate documentation was reviewed.Dhr review for the lot: (1221318) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot: (1221318) and no similar event or complaint was found.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11364629
• Report Number: 0002023141-2021-00444
• Device Sequence Number: 934759
• Product Code: DZE
• UDI-Device Identifier: 00889024343917
• UDI-Public: (01)00889024343917(17)231012(10)1221318(241)CT318
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: CT318
• Device Catalogue Number: CT318
• Device Lot Number: 1221318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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
• Patient Age: 88 YR