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

Model Number MOSS 100 PEDICLE SCREW

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/09/2021

Event Type  Injury  

Event Description

It was reported a revision surgery was required due to "non-union" (non-integration).It was reported all biedermann hardware was remove from the patient.There were no reports of patient impact as a result of this revision surgery.Product will not be returned.

• Brand Name: MOSS 100 SYSTEM
• Type of Device: MOSS 100 PEDICLE SCREW SYSTEM
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner-str. 23; villingen-schwenningen, 78054 ; GM 78054
• MDR Report Key: 11824898
• MDR Text Key: 250613058
• Report Number: 3013248720-2021-00006
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021,05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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 AVAIABLE
• Device Lot Number: INFORMATION NOT AVAIABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2021
• Distributor Facility Aware Date: 04/14/2021
• Event Location: Other
• Date Report to Manufacturer: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INFORMATION NOT AVAILABLE
• Patient Outcome(s): Required Intervention