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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported implants were removed due to fracture.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).First/given name: unknown / not provided.Pma/510(k) number: k011028 and k013227.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: unique identifier (udi) number information g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).An impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm (tsvb11), imp,tsv,mcol mg,3.7mm,11.5mml (tsvmb11), impl scr-v mini sbm 3.3mm 3.5mm 13mm (svmb13) were returned for investigation.Visual inspection of the as returned products identified worn markings due to usage with bone/debris and a fracture at the collars of all implant and screw fractures inside the tsvmb11 and svmb13.Device history record (dhr) review was completed for the subject lot number (62443572, 1226004 and 63341049).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (62443572, 1226004 and 63341049) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available 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: 13887755
• Report Number: 0002023141-2022-00705
• Device Sequence Number: 11012922
• Product Code: DZE
• UDI-Device Identifier: 00889024018136
• UDI-Public: (01)00889024018136(17)210531(10)63341049
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2022

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: 05/31/2021
• Device Model Number: SVMB13
• Device Catalogue Number: SVMB13
• Device Lot Number: 63341049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 08/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 08/30/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2016
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG