MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL STERILE SPACER 8 X 25 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 48385084S

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device are currently unknown.

Event Description

It was reported during a medical procedure that an implanted avs tl cage had fractured.No additional information is known at this time.No adverse consequences or medical intervention were reported.

Event Description

It was reported during a medical procedure that an implanted avs tl cage had fractured.No additional information is known at this time.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

Visual inspection of the returned found the area around the threading to be deformed, likely due to force applied in an attempt to insert/thread the inserter into the cage.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: identify the appropriate size avs tl peel spacer and assemble it to either the straight or angled, based on surgeon preference.Slide the collet into the insertion hole of the avs tl implant.Close the lever on the handle and the collect expands, capturing the avs tl implant.Close the lever on the handle and the collect expands, capturing the avs tl implant.Risk table states that excessive or incorrect force type applied during attaching implant to inserter can cause damage to implant.Based on visual inspection and risk table, root cause of reported event is most likely excessive/ incorrect force applied to attach implant to inserter.

• Brand Name: AVS TL STERILE SPACER 8 X 25 X 4 DEG
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8972980
• MDR Text Key: 174708757
• Report Number: 0009617544-2019-00108
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K151726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48385084S
• Device Lot Number: 80298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1