MAUDE Adverse Event Report: SPINAL PACK (SURGICAL BLADES); ORTHOPEDIC TRAY

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/30/2019

Event Type  Injury  

Event Description

Surgical blade broke off during lumbar spinal surgery and approx 7mm was retained within the lumbar disc space.Fda safety report id# (b)(4).

• Brand Name: SPINAL PACK (SURGICAL BLADES)
• Type of Device: ORTHOPEDIC TRAY
• MDR Report Key: 8671554
• MDR Text Key: 147294630
• Report Number: MW5087140
• Device Sequence Number: 1
• Product Code: OJH
• 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: 05/31/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR