MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	OSS413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).Patient's weight was not provided.
Event or Problem Description
It was reported that the implant fractured.The implant was not completely removed in order to not cause any damage to the patient.Patient will return for additional appointments for new implant placement.Tooth number 13.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® implant 4 x 13mm (oss413) and locator were returned for investigation.Visual evaluation of the as returned products identified a fractured implant engaged with the locator.There were no allegations against the locator.Therefore, the investigation was performed only on the implant.Functional testing and dimensional analysis could not be performed since the implant was fractured.No pre-existing conditions were noted on the per.The reported device had been placed on tooth # 13 (fdi) for approximately 2 years.Device history record (dhr) review for the lot (2017111748) 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 completed for the subject lot number (2017111748).No other complaints about nonconforming products were identified.Therefore, based on 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).One osseotite® implant 4 x 13mm (oss413) was not returned for investigation.Therefore, visual evaluation could not be performed.Upon product receipt, cmp and pce will be reopened and updated accordingly.The investigation was performed using the applicable instructions for use and risk files.Functional testing and dimensional analysis could not be performed since the device was not returned.No pre-existing conditions were noted on the per.The reported device had been placed on tooth # 13 (fdi) for approximately 2 years.Picture image was provided and fracture was identified at the apical part of the implant.The device history record (dhr) was not available electronically for the subject lot number (2017111748) 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 for valencia lots (non-conformance list) was conducted with the lot number to discover any non-conformances related to the reported event and subject lot number.No non-conformances were found for the subject lot number.Complaint history review was completed for the subject lot number (2017111748).No other complaints about nonconforming products were identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed following picture evaluation.

• Brand Name: OSSEOTITE IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10088265
• Report Number: 0001038806-2020-00792
• Device Sequence Number: 2342261
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)221211(10)2017111748(241)OSS413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/11/2022
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 2017111748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 08/10/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/14/2020; 09/03/2020
• 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: 81 YR