MAUDE Adverse Event Report: IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM; DENTAL IMPLANT

Model Number	ILOA001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Additional pma/510(k) number ¿ k011028, k013227.A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external factors (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
The clinician reported attempting to place an implant in tooth site #4.The implant would not tighten up and obtain stability.The patient will return in two (2) months for a new implant.Placement.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.The following sections are being reported: b4: date of this report was updated.D4: lot number was corrected/updated.D4: unique device identifier was corrected/updated.D4: device expiration date was corrected/updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was corrected/updated.H10: narrative/data was updated.
Event or Problem Description
Customer corrected the device lot number.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
• Common Device Name: DENTAL IMPLANT
• MDR Report Key: 12638413
• Report Number: 0002023141-2021-02908
• Device Sequence Number: 3451481
• Product Code: DZE
• UDI-Device Identifier: 00844868006060
• UDI-Public: (01)00844868006060(17)240326(10)1226908
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 Expiration Date: 04/23/2024
• Device Model Number: ILOA001
• Device Catalogue Number: TSV6B10
• Device Lot Number: 1226906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR