MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX,13MM; DENTAL IMPLANT

Model Number	TMMB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).Weight unknown/not provided.Expiration date and unique identifier (udi) number unknown/not provided.Device manufacturer date unknown/not provided.
Event or Problem Description
It was reported that the implant could not be placed due to fracture of the patient's bone.The site was grafted for future placement.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection of the returned product identified worn markings due to usage.No damage.Measurements were made to determine if the device matched print specification and it was confirmed to match the drawing specifications.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 product experience report (per).The reported device was intended for tooth location #6 but could not be placed.Pictures or x-ray images were not provided.Complainant reported that the implant could not be placed due to fracture of the patient's bone.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.

• Brand Name: IMP TM 3.7MM MTX,13MM
• 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: 14652505
• Report Number: 0002023141-2022-01450
• Device Sequence Number: 11991789
• Product Code: DZE
• UDI-Device Identifier: 00889024018884
• UDI-Public: (01)00889024018884(17)241013(10)1232413
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: TMMB13
• Device Catalogue Number: TMMB13
• Device Lot Number: 1232413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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: 62 YR
• Patient Sex: Female