MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 14M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPB14
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: pma/510(k) number : k011245 and k002188.
Event or Problem Description
It was reported cortical lingual perforation at tooth site (b)(6) with edema and inflammation.Patient referred pain.No other implant was placed to complete the procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Investigation summary: the complaint reported cortical lingual perforation at tooth site 33 with edema and inflammation.Patient referred pain.No other implant was placed to complete the procedure.One implant tapered sp, (spb14) was returned for investigation.Visual/physical evaluation of the as returned product identified signs of use but no apparent signs of malfunction.Functional testing could not be performed due to that nature of the device and event.Dhr review was completed for the subject lot number 2020050175.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 2020050175 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿bone fracture¿.The customer did not submit images for the reported event.Instructions for use ¿ swissplus® and tapered swissplus® implants, ifu9667 rev 2 - 10/19.Information identified: contraindications, warnings, precautions and breakage.Per the applicable ifu, zimmer dental implants should not be placed if there is an insufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical).Implants placed in the maxilla should not perforate the sinus floor membrane.Poor bone quality, poor patient oral hygiene, heavy tobacco use, uncontrolled systematic diseases (diabetes, etc.), reduced immunity, alcoholism, drug addiction, and psychological instability may contribute to lack of integration and/or subsequent implant failure.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was placement of implant in a patient with patient factors incompatible with osseointegration of implant ¿ customer error (improper techniques used in poor bone quality).Therefore, based on the available information, device malfunction has not occurred.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 14M M 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 ; 5617766700
• MDR Report Key: 17116024
• Report Number: 0002023141-2023-01663
• Device Sequence Number: 12424443
• Product Code: DZE
• UDI-Device Identifier: 00889024017191
• UDI-Public: (01)00889024017191(17)250525(10)2020050175
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/05/2023

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: Other
• Device Expiration Date: 05/25/2025
• Device Catalogue Number: SPB14
• Device Lot Number: 2020050175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic