MAUDE Adverse Event Report: STRYKER SPINE CAGE 9X25X4*; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 48485094

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

Doctor went to tap in the cage and then working around it, the cage cracked and broke into 4 pieces.It was faulty and the rep from stryker was present.Manufacturer response for cage 9x25x4*, (brand not provided) (per site reporter).
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stryker sales reps were present for the surgery.They wanted to immediately take and send product in for a qa.

• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE; 2 pearl court; allendale NJ 07401
• MDR Report Key: 3945822
• MDR Text Key: 15994426
• Report Number: 3945822
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 48485094
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2014
• Patient Sequence Number: 1
• Patient Age: 69 YR