MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM

Model Number SCREW Ø6MM LENGHT UNKOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2021

Event Type  Injury  

Event Description

The patient had very hard sclerotic bone and when placing one pedicle screw without using a tap, the tip of the cannulated screw driver was broken.The surgery continued without delay.When inserting another pedicle screw a tap was used but only for the first 20mm of the screw trajectory.The neck of this screw broke during the final insertion turn with a solid screw driver.As the construct involved multiple pedicle screws, the surgeon decided to leave the shaft of the pedicle screw in the bone and the surgery continued without delay.

• Brand Name: MOSS 100 SYSTEM
• Type of Device: MOSS 100 SYSTEM
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; berth-von suttner str. 23; villingen-schwenningen, 78054 ; GM 78054
• Manufacturer Contact: gerd federle ; bertha-von-suttner str. 23; villingen-schwenningen, 78054 ; GM 78054
• MDR Report Key: 11576308
• MDR Text Key: 251424726
• Report Number: 8010944-2021-00002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K162232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCREW Ø6MM LENGHT UNKOWN
• Device Catalogue Number: INFORMATION NOT AVAILABLE
• Device Lot Number: INFORMATION NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other