MAUDE Adverse Event Report: CONVENTUS ORTHOPAEDICS, INC. CONVENTUS PHS SYSTEM; NAIL, FIXATION, BONE

Model Number	PH-M
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.Follow-up report(s) will be submitted upon obtaining any additional information.
Event or Problem Description
On (b)(6) 2019, the surgeon implanted conventus ph cage in the left arm of the patient.On (b)(6) 2019, the patient fell on her left arm.Around (b)(6) 2019 (the exact date unknown), the surgeon identified that the ph cage had slipped into varus and decided to remove a screw applied to the ph cage.On (b)(6) 2019, the screw was removed.On (b)(6) 2019, the surgeon identified the patient had an infection at the implant site and decided to remove the ph cage implanted on (b)(6) 2019.On (b)(6) 2019, the ph cage was removed.

• Brand Name: CONVENTUS PHS SYSTEM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite122; maple grove MN 55369
• MDR Report Key: 9101193
• Report Number: 3008480376-2019-00003
• Device Sequence Number: 2950526
• Product Code: JDS
• UDI-Device Identifier: 00814289020709
• UDI-Public: (01)00814289020709(10)10331(17)20210110
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2019

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: 01/10/2021
• Device Model Number: PH-M
• Device Lot Number: 10331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: 70 YR