MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC STAINLESS STEEL RATCHET; DENTAL IMPLANT

Model Number	R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), during clinical procedure, ratchet wrench was stripped.Ratchet wrench did not allow implant to be placed in extraction site.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date.Updated g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.Information for section a4, b3, d6b, were not available.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation (b)(4).

• Brand Name: STAINLESS STEEL RATCHET
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9207909
• Report Number: 3001617766-2019-04751
• Device Sequence Number: 11539991
• Product Code: NDP
• UDI-Device Identifier: 10841307119234
• UDI-Public: 10841307119234
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R
• Device Catalogue Number: R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/28/2021
• 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: 61 YR