MAUDE Adverse Event Report: IMPLANET JAZZ; JAZZ BAND

Model Number 150156

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/11/2020

Event Type  Injury  

Event Description

For unknown reason a patient was revised on (b)(6) 2020.During this new surgery, the physician took out a jazz band because it was broken.Initial surgery was on (b)(6) 2018.

• Brand Name: JAZZ
• Type of Device: JAZZ BAND
• Manufacturer (Section D): IMPLANET; technopole bordeaux montesquie; allee françois magendie; martillac, nouvelle aquitaine 33650 ; FR 33650
• Manufacturer (Section G): IMPLANET; technopole bordeaux montesquie; allee francois magendie; martillac, 33650, fr,
• Manufacturer Contact: regis le couedic ; technopole bordeaux montesquie; allee francois magendie; martillac, 33650, fr,
• MDR Report Key: 9852259
• MDR Text Key: 189310279
• Report Number: 3007675554-2020-00001
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 150156
• Device Catalogue Number: 350156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2020
• Distributor Facility Aware Date: 02/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention