MAUDE Adverse Event Report: CITIEFFE S.R.L. RONDO; TITANIUM CANNULATED SCREW

Model Number	Screw ø4mm L40mm
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The screw was removed for implant site infection.

• Brand Name: RONDO
• Common Device Name: TITANIUM CANNULATED SCREW
• Manufacturer (Section D): CITIEFFE S.R.L.; via armaroli, 21; calderara di reno, bologna 40012 ; IT 40012
• MDR Report Key: 10244410
• Report Number: 3003249380-2020-00002
• Device Sequence Number: 803669
• Product Code: HWC
• UDI-Device Identifier: 08032909622429
• UDI-Public: (01)08032909622429(17)220726(10)0PG072630000
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: Screw ø4mm L40mm
• Device Catalogue Number: VP-14040
• Device Lot Number: 0PG072630000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/08/2020
• 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: 42 YR