MAUDE Adverse Event Report: BIOMET 3I DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 10MM; DENTAL IMPLANT

Model Number	OS4510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the patient came to medical office with mobility.When doctor unscrew for check up the implant was fractured and removed.It was also noticed bone loss.
Event or Problem Description
No further event information is available at the time of this report.
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 xp® implant (os4510), and associated screw were returned for investigation.There were no allegations against the reported screw.Therefore, this investigation was conducted only on the implant.Visual evaluation of the as returned implant identified that the upper part was fractured off.Additionally, there was bone residue around the external threads (damaged possibly during removal) due to usage.Functional testing and dimensional analysis could not be performed since the device was fractured.Pre-existing condition noted on the per was 'moderate bone density ¿ type ii'.The reported device had been placed on tooth # 26 (fdi) for approximately 11 years.X-ray or picture image was not provided.As a result, bone loss could not be verified.Document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g - october 2019.Per the applicable ifu, it is stated that breakage of implant and loss of supporting bone may occur when device is loaded beyond its functional capability.Dhr review for the lot (2009071078) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.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 reported lot (2009071078) and no similar event or complaint was found.December post market trending was reviewed and there were no actionable trends or corrective actions for the reported device and events.Therefore, based on the available information, device malfunction did occur and the reported implant fracture was confirmed.However, bone loss could not be verified as the exact details of event and patient anatomical condition were non-verifiable.

• Brand Name: DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10884353
• Report Number: 0001038806-2020-01883
• Device Sequence Number: 16965171
• Product Code: DZE
• UDI-Device Identifier: 00844868012849
• UDI-Public: (01)00844868012849(17)140701(10)2009071078(241)OS4510
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 07/01/2014
• Device Model Number: OS4510
• Device Catalogue Number: OS4510
• Device Lot Number: 2009071078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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
• Patient Age: 66 YR