MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305006
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the cage was inserted and positioned and the would expand at all.Checked the o rings of syringe body and plunger both were in tact.Checked the tubing on both ends and nothing was damaged.Also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.4 level case, 3 of cages expanded 4th cage didn't expand.Surgeon was satisfied with the position of this cage, as the other 3 cages expanded (xrays will be provided).
Additional Manufacturer Narrative
Lot # 10201506.Method: device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.According to acculif surgical technique the amount of pressure necessary to move the endplate of the device depends on the degree of resistance offered by the remaining soft tissue and ligaments around the discectomy.If the endplate is violated, the surgeon user should collapse the implant.The surgeon should slowly re-expand the implant until it is just snug within the disc space.Be sure to check the expansion under fluoroscopy.Surgeon decided to go with 4 levels surgery event though device indications for use is up to two levels.It is possible that force emulating form 3 cages implanted above l5-s1 level transitioned down to the lowest cage and contributed to difficulty with expanding.Conclusion: the root cause of the reported event may have been implant positioning in a disk space.
Event or Problem Description
It was reported that; the cage was inserted and positioned and it would not expand at all.Checked the o rings of syringe body and plunger both were intact checked the tubing on both ends and nothing was damaged, also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.Four level case, 3 of cages expanded 4th cage didn't expand.Surgeon was satisfied with the position of this cage, as the other 3 cages expanded (xrays will be provided).
Additional Manufacturer Narrative
Update 12/16/2016.Patient experienced pain and will undergo a revision surgery.
Event or Problem Description
It was reported that the cage was inserted and positioned and the would expand at all.Checked the o rings of syringe body and plunger both were in tact checked the tubing on both ends and nothing was damaged also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.Four level case, 3 of cages expanded 4th cage didn't expand.Surgeon was satisfied with the position of this cage, as the other 3 cages expanded update 12/16/2016 patient experienced pain and will undergo a revision surgery.Revision surgery date unknown.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified; conclusion: the root cause of the reported event cannot be determined conclusively as neither x-rays nor explanted device was returned for evaluation.
Event or Problem Description
It was reported that; the cage was inserted and positioned and the would expand at all.Checked the o rings of syringe body and plunger both were in tact.Checked the tubing on both ends and nothing was damaged.Also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.A 4 level case, 3 of cages expanded 4th cage didn't expand.Surgeon was satisfied with the position of this cage, as the other 3 cages expanded.Update 12/16/2016: patient experienced pain and will undergo a revision surgery.Revision surgery date unknown.

• Brand Name: ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5972770
• Report Number: 3004024955-2016-00085
• Device Sequence Number: 1917066
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 305006
• Device Lot Number: 10201506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 11/23/2016; 12/21/2016; 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention