MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 8.5MM; DENTAL IMPLANT

Model Number	OSS385
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.Title unknown/ not provided.First/given name: unknown / not provided.Last name unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that on february an implant was placed with a cover screw.On september doctor performed the second surgery and removed the cover screw to take impressions.Doctor took impressions with no incidence and when placing the healing abutment, it did not screw into the implant.Doctor re-do the internal threads of the implant and implant remains placed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one osseotite® implant (oss385) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files.Functional testing of the drive feature could not be performed since the product was not returned.No pre-existing conditions were noted.The reported device had been placed on an unknown tooth location since february, 2020.X-ray or picture images were not provided.Dhr review for the lot (2019072149) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (2019072149) for similar events and no other complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, the reported malfunction and event could not be verified since the implant was not returned.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE IMPLANT 3.75 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10725062
• Report Number: 0001038806-2020-01621
• Device Sequence Number: 3312449
• Product Code: DZE
• UDI-Device Identifier: 00844868013167
• UDI-Public: (01)00844868013167(17)240903(10)2019072149(241)OSS385
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/01/2020

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: 09/03/2024
• Device Model Number: OSS385
• Device Catalogue Number: OSS385
• Device Lot Number: 2019072149
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1