MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	OSS585
Medical Device Problem Code	Mechanical Problem (1384)
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.Explant date unknown/not provided.Email address unknown/not provided.
Event or Problem Description
It was reported that when taking impressions to place a crown on an implant placed on 2019, the internal thread stripped out.Doctor was not able to place the cover screw, he tried to re-do the thread without success but finnaly managed to place a crown on (b)(6) 2019.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-0637573 the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one osseotite® implant (oss585) was reported but not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use, risks files and other available information.Functional testing could not be performed since the device was not returned.No pre-existing conditions were noted on the per.Impression was being taken to place a crown on the implant (unknown tooth location and unknown implantation duration) when the incident occurred.X-ray or picture images were not provided.Document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g - october 2019.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, under the section precautions, it is stated that improper technique may lead to device failure.Additionally, under warning, it is stated that overloading may cause device failure.Dhr review: dhr review for the lot (2018070999) 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.Complaint history review was performed for the reported lot (2018070999) and no similar event or complaint was found.November 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, device malfunction and the reported event could not be verified since the product was not returned.

• Brand Name: OSSEOTITE IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10696115
• Report Number: 0001038806-2020-01596
• Device Sequence Number: 17118281
• Product Code: DZE
• UDI-Device Identifier: 00844868013303
• UDI-Public: (01)00844868013303(17)230724(10)2018070999(241)OSS585
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 07/24/2023
• Device Model Number: OSS585
• Device Catalogue Number: OSS585
• Device Lot Number: 2018070999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1