MAUDE Adverse Event Report: SPINEWAY MONT BLANC AND MONT BLANC MIS SPINAL SYSTEMS; LOCKING SCREW

Model Number MIS1LS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/18/2019

Event Type  Injury  

Event Description

Patient has undergone a spine surgery on l5-l4 levels.At 3 months-follow up, a locking screw was found outside the screw head on radiography.

• Brand Name: MONT BLANC AND MONT BLANC MIS SPINAL SYSTEMS
• Type of Device: LOCKING SCREW
• Manufacturer (Section D): SPINEWAY; 7 allee moulin berger; ecully, 69130 ; FR 69130
• Manufacturer Contact: héloïse macaire ; 7 allée moulin berger; ecully, 69130 ; FR 69130
• MDR Report Key: 9694268
• MDR Text Key: 189202016
• Report Number: 3010758686-2020-00002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K161387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: MIS1LS
• Device Catalogue Number: MIS1LS
• Device Lot Number: 5181904S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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): Required Intervention
• Patient Age: 40 YR