MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 4.8MM 8MM OCTAGON; DENTAL IMPLANT

Catalog Number	SPWB8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.G4: premarket identification k011245/k002188.
Event or Problem Description
It was reported that during implant placement, the vestibular bone wall fractured, leading to a poor primary stability and most likely implant failure.Doctor decided to remove the implant and schedule a new implant placement after healing period.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) 2023051464, (impl tapered sp 4.8mm 8mm octagon) for evaluation.Visual evaluation was performed, the implant had signs of use with markings from removal.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.Dhr review was completed for the subject lot number 2023051464.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 2023051464 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: bone fracture.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning.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 with all the available information provided.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 4.8MM 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: 18204424
• Report Number: 0002023141-2023-03351
• Device Sequence Number: 6445128
• Product Code: DZE
• UDI-Device Identifier: 00889024017597
• UDI-Public: (01)00889024017597(17)280612(10)2023051464
• 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): 05/12/2024

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: Health Professional
• Device Catalogue Number: SPWB8
• Device Lot Number: 2023051464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• 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: 11/24/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic