MAUDE Adverse Event Report: MEDTRONIC SPINE / MEDTRONIC SOFAMOR DANEK USA, INC. LUMBAR SPINE SCREWS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 557401065505

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2022

Event Type  Injury  

Event Description

Broken hardware needing removal- l4 screw."xxx7540".

• Brand Name: LUMBAR SPINE SCREWS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SPINE / MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 17005120
• MDR Text Key: 316055273
• Report Number: MW5117873
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 557401065505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic