MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE XP® MINIPLANT® 3.25/4 X 11.5MM; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The following information is unknown at the time of this report: date of birth not provided.Weight and ethnicity: not provided.The reported device is not expected for investigation.An investigation will be completed, however.Once the investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the implant fractured at tooth location 19.There was no report of patient injury.
Additional Manufacturer Narrative
The osseotite xp® miniplant® 3.25/4 x 11.5mm (os3211) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on tooth # 19 (universal) and used for approximately 16 years prior to fracture.The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot number 168322.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (168322) for similar cause and no other complaint was identified within the past 2 years.July post market trending was reviewed and there were no negative trends or corrective actions for the reported event (implant fracture) or product (os3211).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The most likely root cause related to the event is patient parafunction over the course of 16 years.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE XP® MINIPLANT® 3.25/4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8735797
• Report Number: 0001038806-2019-00582
• Device Sequence Number: 16787231
• Product Code: DZE
• UDI-Device Identifier: 00844868012795
• UDI-Public: (01)00844868012795(17)070809(10)168322(241)OS3211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 08/09/2007
• Device Model Number: N/A
• Device Catalogue Number: OS3211
• Device Lot Number: 168322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 65 YR