MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 8MM OCTAGON; DENTAL IMPLANT

Catalog Number	SPB8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the dental implant located in position #16 failed due to a sinus perforation.The procedure was not completed with the placement of another implant.The patient did not experience any negative impact on his health.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.E1: reporter name unknown / not provided.G4: premarket identification k011245/k002188.H4: device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp (b)(4) the following fields have been updated: b4: date of this report b5: describe event or problem d3: manufacturer email address d4: additional device information d9: device availability g1: contact office (and manufacturing site for devices) contact name and email 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) spb8, (impl tapered sp 3.7mm 8mm octagon) for evaluation.Visual evaluation / functional test was performed, there was signs of use, the implant had markings from removal.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.Cal05593632.Dhr review was completed for the subject lot number 2022070424.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 2022070424 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : non integration : perforated sinus.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error and patient factors.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.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.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SP 3.7MM 8MM OCTAGON
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18146352
• Report Number: 0002023141-2023-03263
• Device Sequence Number: 7502931
• Product Code: DZE
• UDI-Device Identifier: 00889024017207
• UDI-Public: (01)00889024017207(17)270715(10)2022070424
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082639
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/04/2024

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: SPB8
• Device Lot Number: 2022070424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2023
• 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: 11/16/2023
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic