MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.7,16,MTX,MG; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).0002023141-2019-00592 has also been submitted.Additional 510k: k101880.The following information is unknown at the time of this report: date of birth: unknown.Weight, ethnicity: unknown.A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external (non-design/ non-manufacturing related) factors, identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant at tooth location #13 was unable to be placed into the osteotomy.The patient will return for implant placement.
Event or Problem Description
It was reported that the implant (tsvtwb16) at tooth location #13 was unable to be placed into the osteotomy due to perforation of the sinus floor.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).This submission is being relayed due to a correction in the complaint's description.

• Brand Name: IMP,TSV,4.7,16,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8911231
• Report Number: 0002023141-2019-00591
• Device Sequence Number: 503064
• Product Code: DZE
• UDI-Device Identifier: 00889024020023
• UDI-Public: (01)00889024020023(17)221231(10)63879802
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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 Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: TSVTWB16
• Device Lot Number: 63879802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR