MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS VRS; MOSS VRS IN:SITU TI REDUCTION HEAD POLYAXIAL

Catalog Number 108-017-0002

Device Problem Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

The surgery was conducted in (b)(6) 2023.It was first observed by the physician on (b)(6) 2023 via routine follow-up examination of x-ray that one screw head and one screw shaft were not connected.Fusion had occured and no medical intervention was required.

• Brand Name: MOSS VRS
• Type of Device: MOSS VRS IN:SITU TI REDUCTION HEAD POLYAXIAL
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner strasse 23; villingen-schwenningen 78054 ; GM 78054
• Manufacturer Contact: gerd federle ; bertha-von-suttner strasse 23; villingen-schwenningen 78054 ; GM 78054
• MDR Report Key: 18551543
• MDR Text Key: 333341376
• Report Number: 8010944-2024-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 042508695521
• UDI-Public: (01)042508695521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 108-017-0002
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other