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

Device Problems Failure to Osseointegrate (1863); Patient Device Interaction Problem (4001)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/29/2020

Event Type  Injury  

Event Description

The patient, as reported, has a history of revision surgeries.The first revision surgery was to replace implants from a company other than biedermann motech.The revision surgery was concluded with no known complaints.The subject revision surgery was to correct a loose screw (screw halo).Of the implanted moss 100 system.The surgeon opted to introduce a screw at another site (level).In the process of implanting the screw a tap broke and was removed, reference (b)(4).The surgeon's attempts were unsuccessful and made a judgment call to not continue with any implantation.The patient did not succumb to injuries as a result of the subject revision surgery.

• Brand Name: MOSS 100 SYSTEM
• Type of Device: MOSS 100 SYSTEM
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-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: 10880979
• MDR Text Key: 217657433
• Report Number: 8010944-2020-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other