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

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.Follow-up report(s) will be submitted upon obtaining any additional information.

Event Description

On (b)(6) 2019, a ph cage was removed due to a patient fall that resulted in the cage penetrating the humeral head.

• Brand Name: CONVENTUS PHS SYSTEM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove MN 55369
• Manufacturer (Section G): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove MN 55369
• Manufacturer Contact: kenneth block ; 800 e. campbell road; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 9324254
• MDR Text Key: 167010409
• Report Number: 3008480376-2019-00012
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR