MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V MINI SBM 3.3MM 3.5MM 13MM; DENTAL IMPLANT

Model Number	SVMB13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional 510(k) numbers are k011028 and k013227.
Event or Problem Description
It was reported that the implant was removed due to becoming fractured.Tooth #23.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.H6: health effect clinical code was added: 4582.H6: investigation type codes were added: 3331, 4109, 4110, 4111 and 4114.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.One impl scr-v mini sbm 3.3mm 3.5mm 13mm (svmb13) was not returned for investigation.Therefore, visual evaluation could not be performed in person put picture evidence was provided.The investigation was conducted using applicable instructions for use (ifu), risks files, and picture evidence.Based on the evaluation, device malfunction was verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot (63582758) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number (63582758) for similar events (complaint category keywords: fracture: implant) and one other complaint was identified.Functional testing could not be performed since the product was not returned.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation are improper loading and techniques.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMPL SCR-V MINI SBM 3.3MM 3.5MM 13MM
• 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: 14106433
• Report Number: 0002023141-2022-00911
• Device Sequence Number: 20002611
• Product Code: DZE
• UDI-Device Identifier: 00889024018136
• UDI-Public: (01)00889024018136(17)220331(10)63582758
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 03/31/2022
• Device Model Number: SVMB13
• Device Catalogue Number: SVMB13
• Device Lot Number: 63582758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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 Sex: Male