MAUDE Adverse Event Report: STRYKER STRYKER AERO LL LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48941110

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

A patient was scheduled for a spine decompression with fusion.When the implant was being inserted into the patient, the tip of the implant inserter broke off into the implant that was inserted into the patient.Dates of use: (b)(6) 2017.

• Brand Name: STRYKER AERO LL LUMBAR CAGE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER; kalamazoo MI 49001
• MDR Report Key: 6736074
• MDR Text Key: 80906052
• Report Number: MW5071153
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/29/2020
• Device Catalogue Number: 48941110
• Device Lot Number: 14G509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1