MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Model Number	OSS511
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that implant's head is round and all crowns on it move.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-0765704 the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.H4: device manufacture date not available, lot number unknown.One osseotite® implant 5 x 11.5mm (oss511) was returned for investigation.Visual evaluation of the as returned product identified damaged internal drive feature and signs of use (bone residue).Additionally, implant collar and body were damaged possibly during removal.Damage observed on returned implants due to trephine removal is not considered a malfunction or failure of the device.Zimmer biomet is not responsible for any damage caused by the clinician's removal of the device.Functional testing was not performed due to the nature of the device and event.No pre-existing conditions were noted.The device was intended for tooth 16 (fdi).X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h - july 2021.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, improper techniques as well as overloading may lead to device failure.Dhr review: dhr review for the lot (2018112230) 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: complaint history review was performed for the reported lot number (2018112230) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Post market trending review: february post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE® IMPLANT 5 X 11.5MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13257457
• Report Number: 0001038806-2022-00051
• Device Sequence Number: 13878471
• Product Code: DZE
• UDI-Device Identifier: 00844868013266
• UDI-Public: (01)00844868013266(17)240102(10)2018112230
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 01/02/2024
• Device Model Number: OSS511
• Device Catalogue Number: OSS511
• Device Lot Number: 2018112230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male