MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF SYRINGE BODY; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 800247

Device Problems Fluid/Blood Leak (1250); Activation Failure (3270)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that; after getting cage in position we went to expand and engaged the syringe to the inserter.Doctor then began to turn the syringe dial to expand and the saline started leaking out at the point of contact between the syringe and the inserter (where the green clip clicks over the inserter body).We removed and inspected both the red and green washer.Both were fine.We re-attached the syringe to the inserter and still an issue with the saline leaking and the cage not expanding.Doctor then began to push the syringe into the inserter to tighten the seal between both.We were able to dial and expand the cage up.However, it was not ideal and the cage didn't expand very easily.

Manufacturer Narrative

Method: device inspection & device history review.Results: no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Upon visual inspection of the returned instrument it was confirmed that the syringe body green o-ring was broken.Conclusion: the plausible root cause of the reported event is design related.

Event Description

It was reported that; after getting cage in position we went to expand and engaged the syringe to the inserter.Doctor then began to turn the syringe dial to expand and the saline started leaking out at the point of contact between the syringe and the inserter (where the green clip clicks over the inserter body).We removed and inspected both the red and green washer.Both were fine.We re-attached the syringe to the inserter and still an issue with the saline leaking and the cage not expanding.Doctor then began to push the syringe into the inserter to tighten the seal between both.We were able to dial and expand the cage up.However, it was not ideal and the cage didn't expand very easily.

• Brand Name: ACCULIF SYRINGE BODY
• 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: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4671971
• MDR Text Key: 5734090
• Report Number: 3004024955-2015-00030
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 800247
• Device Lot Number: 03181402-098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1