MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 8X50MM; SPINE PEDICLE SCREW

Model Number 03.50.056

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/16/2022

Event Type  Injury  

Event Description

Revision surgery due to screw loosening.2 screws were exchanged with 10x50 mm.Primary surgery date unknown.The patient's bone was slightly osteoporotic according to the surgeon.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 8X50MM
• Type of Device: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13803783
• MDR Text Key: 287430179
• Report Number: 3005180920-2022-00178
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030834431
• UDI-Public: 07630030834431
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.50.056
• Device Catalogue Number: 03.50.056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White