MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX,10MM; DENTAL IMPLANT

Model Number	TMMB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.
Event or Problem Description
It was reported that the implant at tooth site #47 fractured above the trabecular metal portion and it was completely removed.
Additional Manufacturer Narrative
One implant was returned for investigation.Inspection of the as returned product confirmed that the device is fractured.A device history review was performed and no related nonconformance¿s were noted.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.The alleged device malfunction was confirmed.A root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TM 3.7MM MTX,10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9860475
• Report Number: 0002023141-2020-00618
• Device Sequence Number: 2874775
• Product Code: DZE
• UDI-Device Identifier: 00889024018860
• UDI-Public: (01)00889024018860(17)210630(10)63390565(241)TMMB10
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TMMB10
• Device Catalogue Number: TMMB10
• Device Lot Number: 63390565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: 75 YR
• Patient Weight: 80