MAUDE Adverse Event Report: BIOMET 3I DO NOT USE - OSSEOTITE XP MINIPLANT 3.25/4 X 11.5MM; DENTAL IMPLANT

Model Number	OS3211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.
Event or Problem Description
Doctor reported the patient came with the crown in his hand, the implant was fractured and was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite xp® miniplant® 3.25/4 x 11.5mm (os3211) was returned for investigation.Visual evaluation of the as returned product identified that it was severely fractured/damaged.Additionally, there was bone residue around the external threads due to usage.Device history record (dhr) review for the lot (2012032195) 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 reported lot (2012032195) and no similar event or complaint was found.Therefore, based the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: DO NOT USE - 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: 10725764
• Report Number: 0001038806-2020-01634
• Device Sequence Number: 19661427
• Product Code: DZE
• UDI-Device Identifier: 00844868012795
• UDI-Public: (01)00844868012795(17)170418(10)2012032195(241)OS3211
• 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: 2013
• 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): 01/29/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/18/2017
• Device Model Number: OS3211
• Device Catalogue Number: OS3211
• Device Lot Number: 2012032195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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