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

Model Number	SPB14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Additional 510k numbers: k011245 and k002188.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
It was reported that the implant could not achieve primary stability.The implant was removed.
Event or Problem Description
Additional information identified that another implant was able to be placed, making this case a same day replacement.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2019 identified that another implant was able to be placed, making this case a same day replacement.This event no longer meets reportability requirements.Therefore, no further medwatch reports will be submitted for this event.

• Brand Name: IMPL TAPERED SP 3.7MM 14M M OCTAGON
• Common Device Name: DENTAL IMPANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9576158
• Report Number: 0002023141-2020-00059
• Device Sequence Number: 11407789
• Product Code: DZE
• UDI-Device Identifier: 00889024017191
• UDI-Public: (01)00889024017191(17)221130(10)63739317
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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 Expiration Date: 11/30/2022
• Device Model Number: SPB14
• Device Catalogue Number: SPB14
• Device Lot Number: 63739317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 63