MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL LUMBAR CAGE 30 * 38MM, 17MM, 12 DEG.; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48923072

Device Problems Bent (1059); Failure to Advance (2524); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

It was reported that; blade malfunctions during case.Two levels.L4-5 was first, l5-s1 was second.First device went in fine, wasn't till after that we noticed the bottom left blade had bent down at an almost 90 degree angle.Second cage went in and once we removed the inserter we noticed one blade had completely sheared off, leaving the actual anchor inside and 'docked' or locked in.This was the bottom left blade.The top left blade did not seat or lock in all the way and when tried to tamp it in, it bent sideways rather than advance.About 15 minutes surgical delay.The damaged blades were not replaced, believes the patient is doing fine.

Manufacturer Narrative

Method: device not returned; results: no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.However, the pilot cutter was not used and it was indicated that patient had hard bone and this could of been the contributing factor.Conclusion: since the complaint devices are still implanted in the patient, the root cause could not be determined conclusively.

Event Description

It was reported that; blade malfunctions during case.Two levels.L4-5 was first, l5-s1 was second.First device went in fine, wasn't till after that we noticed the bottom left blade had bent down at an almost 90 degree angle.Second cage went in and once we removed the inserter we noticed one blade had completely sheared off, leaving the actual anchor inside and 'docked' or locked in.This was the bottom left blade.The top left blade did not seat or lock in all the way and when tried to tamp it in, it bent sideways rather than advance.About 15 minutes surgical delay.The damaged blades were not replaced, believes the patient is doing fine.

• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4910325
• MDR Text Key: 21117889
• Report Number: 3004024955-2015-00059
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48923072
• Device Lot Number: 145809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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