MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS TL SPACER 9 X 25 X 4 DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48385094

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/17/2017

Event Type  Injury  

Event Description

It was reported that; doctors implanted cage, reflecting the cage head is too large, difficult to implant, the need for greater distraction of the vertebral body, will affect the operation results.

Manufacturer Narrative

Method: device history review, complaint history review, risk assessment.Result: no device was returned as it remain implanted so device evaluation could not be performed.Device history review was performed and no relevant manufacturing issues were found.Conclusion: the reported event indicates user preference, and does not reasonably suggest that the device has malfunctioned.

Event Description

It was reported that; doctors implanted cage, reflecting the cage head is too large, difficult to implant, the need for greater distraction of the vertebral body, will affect the operation results.

• Brand Name: AVS TL SPACER 9 X 25 X 4 DEG
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6640517
• MDR Text Key: 77550647
• Report Number: 0009617544-2017-00244
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48385094
• Device Lot Number: 79401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 61