MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Catalog Number	IOSS485
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sinus Perforation (2277); Osteolysis (2377)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported implant placed in a free maxillary side (left superior crestal) maxillary sinus.The implant was placed with primary fixation without drilling.It was used osteodensers and bone dilators.One month later the implant had mobility, peri-implantatis and slightly sinus perforation.Inflammation reported as a consequence of the event.Bone regeneration performed.Tooth location 26.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) ioss485, (4.0mm acid etched ice osseotite ic implant) for evaluation.Visual evaluation was performed.The implant had signs of use with markings from removal.It had a cover screw attached.The implant had debris on its external threads.No damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.Dhr review was completed for the subject lot number 2023040202.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2023040202 for similar events and no other complaint was identified.Review completed utilizing keywords: perforated sinus + peri-implantitis.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was user error/patient factors.Refer to attached summary investigation for peri-implantitis.Therefore, based on the available information, a device malfunction did not occur.Implant was returned with no damage that would cause or contribute to the event.The reported event could not be verified with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Peri-implantitis is an infectious disease that causes inflammation of the gum and the bone structure around a dental implant.Chronic inflammation causes bone loss, which can lead to implant failure thus its removal.Investigations performed for hundreds of events where either of these conditions, infection, or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, and when right conditions prevail and led to peri-implantitis whether reported or not along with the other two, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: OSSEOTITE CERTAIN IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18942819
• Report Number: 0001038806-2024-00498
• Device Sequence Number: 8405474
• Product Code: DZE
• UDI-Device Identifier: 00844868007142
• UDI-Public: (01)00844868007142(17)280420(10)2023040202
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2024

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: Lay User/Patient
• Device Catalogue Number: IOSS485
• Device Lot Number: 2023040202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic