MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT BONE SCREW O 6,5 L 25 MM; BONE CANCELLOUS BONE SCREW LPH, LZO

Catalog Number 01.32.6525

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/16/2015

Event Type  Injury  

Event Description

During surgery, the doctor was implanting a 25mm bone screw.During the final seating of the screw the head snapped off the shaft of the screw.The surgeon left the screw in situ and proceeded to move forward with the case.Mfr ref # 3005180920-2015-00056.

• Brand Name: MPACT BONE SCREW O 6,5 L 25 MM
• Type of Device: BONE CANCELLOUS BONE SCREW LPH, LZO
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ

Manufacturer Contact

• MDR Report Key: 4707505
• MDR Text Key: 5719301
• Report Number: 3006639916-2015-00056
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown,unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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 Expiration Date: 10/31/2019
• Device Catalogue Number: 01.32.6525
• Device Lot Number: 145877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Distributor Facility Aware Date: 03/16/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other