MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,3.7,16,MTX,MG; DENTAL IMPLANT

Model Number	DTN3215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2021
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 the implant in site 27 was placed with allograft and there was some loss of buccal bone while placing implant.No further impact to patient.New implant will be placed after graft heals.No medical history reported.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report b5: describe event or problem d4: lot/serial # d4: device expiration date d4: device udi number g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h4: device manufacturer date h10: added manufacturer narrative.
Event or Problem Description
Sales rep called from doctors office and stated that while placing the implant the buccal plate fractured, so they were unable to place the implant.Site was grafted.
Additional Manufacturer Narrative
An imp,tsv,3.7,16,mtx,mg (tsvtb16) was returned for investigation, see attached images a026 and a027 in the complaint.Visual inspection of the as returned product identified worn markings due to usage.No damage.The returned device was measured verified to match dhr specifications per drawing.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device was located on tooth # 27 and was used same day.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1216494).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1216494) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.The following sections have been updated: g6: checked "follow-up" h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TSV,3.7,16,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12682477
• Report Number: 0002023141-2021-02983
• Device Sequence Number: 1207669
• Product Code: DZE
• UDI-Device Identifier: 00844868002741
• UDI-Public: (01)00844868002741(17)220801(10)1216464
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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: 07/19/2023
• Device Model Number: DTN3215
• Device Catalogue Number: TSVTB16
• Device Lot Number: 1216494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 03/02/2022; 03/22/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 03/02/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female