MAUDE Adverse Event Report: BIOMET 3I 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	BOES413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported implant removed due to allergic reaction.Patient had inflammation as a consequence of the event.Doctor replaced the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One 3i t3® ex hex parallel walled implant (boes413) was returned for investigation.Visual evaluation of the as returned implant identified signs of blood and bone residue around the external threads due to usage.There was no apparent malfunction with the device.The device could not be functionally tested for the reported failure (allergic reaction).The dhr was not available electronically for the subject lot number (2017070317) thus could not be further reviewed at the time of the investigation.No non-conformances were found for the subject lot number.Complaint history review was performed for the reported lot (2017070317) and no similar event or complaint was found.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event and patient post-placement conditions were unknown/nonverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10470571
• Report Number: 0001038806-2020-01256
• Device Sequence Number: 2147077
• Product Code: DZE
• UDI-Device Identifier: 00844868032465
• UDI-Public: (01)00844868032465(17)220718(10)2017070317(241)BOES413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: BOES413
• Device Catalogue Number: BOES413
• Device Lot Number: 2017070317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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