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	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported implant was removed due to fracture.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Product evaluation: one osseotite xp® implant 4/5 x 10mm (os4510) was returned for investigation.Visual evaluation of the as returned product identified that the devices was fractured; there was also bone residue around the external threads due to usage.Functional testing and dimensional analysis could not be performed since the devices were fractured.Pre-existing condition noted on the per is bruxism.The reported device had been placed on tooth 15 (universal) for approximately 14 years.Picture image was provided and fracture was confirmed.Biomet 3i dental implant ifu (p-iis086gi) rev g - october 2019.Per the applicable ifu, it is stated that breakage may occur when device is loaded beyond its functional capability.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.The dhr was not available electronically for the subject lot number (494195) thus could not be further reviewed at the time of the investigation.A notification/request has been sent to manufacturing to pull the dhr for review.The pce will be reopened and updated if there is any indication of non-conformance, or any possible manufacturing issue related to the reported event.Since the dhr was not available, a search in the non- conformance database (tipqa) was conducted with the lot numbers to discover any non-conformances related to the reported event and subject lot numbers.No non-conformances were found for the subject lot numbers.Complaint history review was completed for the subject lot number (494195).No other complaints about nonconforming products were identified.May post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed following picture evaluation.

• 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: 10166909
• Report Number: 0001038806-2020-00855
• Device Sequence Number: 1761934
• Product Code: DZE
• UDI-Device Identifier: 00844868012849
• UDI-Public: (01)00844868012849(17)110329(10)494195(241)OS4510
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 03/29/2011
• Device Model Number: OS4510
• Device Catalogue Number: OS4510
• Device Lot Number: 494195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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
• Patient Age: 70 YR