MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS 100 SYSTEM; MOSS100 SYSTEM

Model Number MOSS 100 PEDICLE SCREW

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/17/2021

Event Type  Injury  

Event Description

There was a revision surgery was to replace a loose screw.The surgeon opted to remove the ø7.0mm screw on the bottom right side, and replace the subject screw with a biedermann ø8.0mm pedicle screw.Additionally, the upper screws of the construct were removed and replaced with competitor's ø9.0mm screws.The surgeon was able to complete the surgery without reported delays.There are no reports of impact on the patient's outcome as a result of the revision surgery.Product will not be returned.

• Brand Name: MOSS 100 SYSTEM
• Type of Device: MOSS100 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-schwennigen, 78054 ; GM 78054
• MDR Report Key: 11575470
• MDR Text Key: 242470935
• Report Number: 8010944-2021-00001
• 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: 03/26/2021

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: MOSS 100 PEDICLE SCREW
• Device Catalogue Number: INFORMATION NOT AVAILABLE
• Device Lot Number: INFORMATION NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other