MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	FOSM310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
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 that during dental surgery the implant packaging was missing.Packaging was correclty sealed.Surgery was completed with another implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite® implant 3.25 x 10mm (fosm310) was not returned for investigation.Since the product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information using the item # and lot # of the reported device (dhr/ifu/rmf).No product experience report (per) was provided.Pre-existing patient factors and tooth location are not related to the reported event.The devices were reported during initial use.The customer provided two pictures showing opened outer boxes of the reported devices with the tamper evident seal broken.The received condition of the products when they reached the customer cannot be verified.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional complaints for this lot.Based on the visual inspection, the packaging malfunction could not be verified for both devices.A definitive root cause could not be identified.The following sections have been updated: b4: date of this report.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® IMPLANT 3.25 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9523173
• Report Number: 0001038806-2019-01695
• Device Sequence Number: 19508868
• Product Code: DZE
• UDI-Device Identifier: 00844868003908
• UDI-Public: (01)00844868003908(17)191126(10)2014090896(241)FOSM310
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2019
• Device Model Number: FOSM310
• Device Catalogue Number: FOSM310
• Device Lot Number: 2014090896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/19/2020
• 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