MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 305008

Device Problems Collapse (1099); Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Event Description

It was reported that cage lost height post-operatively.The patient was in continual back and severe radicular pain.A revision surgery has been scheduled on (b)(6) 2019.

Event Description

The device was implanted (b)(6) 2016.In (b)(6) 2017 the patient began to experience pain, numbness, tingling, sensitivity to the touch, the sensation of swelling, and poor balance.A subsequent lumbar mri indicated restrolisthesis at l3/l4.The physician noted that the cage looks as if it has lost height and then migrated.Revision surgery was performed (b)(6) 2019.The physician was unable to explant the device and instead performed adjacent surgery at l3/l4 and "tamped the [device] back into the disc space.".

Manufacturer Narrative

Visual, dimensional, functional and materials analysis could not be performed as the device remains implanted.A review of complaint and device history records were reviewed and no relevant manufacturing issues nor similar events were identified.The loss of height of a cage was confirmed via x-ray.Due to image quality provided, the level of height reduction cannot be measured.Medical records provided and it¿s unclear if reduction of cage high contributed to the patient's symptoms.The patient did not experience fall/trauma after the initial surgery.It was reported that the surgeon was unable to remove the implant, therefore, he tamped it back into the disc space.X-rays were reviewed with the r&d engineers and a medical professional.The supplemental fixation was used as indicated in the stg, the implant size used appears appropriate, x-rays do not show proper implant placement, implant is a bit posterior and is not on the anterior apophyseal ring, and does not appear to be fully rotated.The reduction of height was noticed approximately 2 years after the initial surgery, per medical records the patient achieved full fusion, therefore, implant performed its indication.According to the surgical technique the following factors may result in early post-operative loosening of an implant: ¿inadequate initial fixation, latent infection, premature loading of the device or trauma.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.¿ ¿implants are intended for use as interbody fusion devices.According to ifu: ¿the surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity, trauma, and that the device may need to be replaced in the future.¿ a plausible root cause of height reduction and migration cannot be identified conclusively.Potential root causes are: initial implant placement, off-axis loading during implant expansion step (it appears that the cage was initially expanded unevenly).

Event Description

The device was implanted (b)(6) 2016.In (b)(6) 2017, the patient began to experience pain, numbness, tingling, sensitivity to the touch, the sensation of swelling, and poor balance.A subsequent lumbar mri indicated restrolisthesis at l3/l4.The physician noted that the cage looks as if it has lost height and then migrated.Revision surgery was performed (b)(6) 2019.The physician was unable to explant the device and instead performed adjacent surgery at l3/l4 and "tamped the [device] back into the disc space.".

Manufacturer Narrative

Stryker was made aware of a device complaint on 22/jan/2019.On 11/apr/2019, additional information was provided.Device remains implanted.

• Brand Name: ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE
• 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: 8315418
• MDR Text Key: 135382630
• Report Number: 3004024955-2019-00004
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: 07613327068054
• Combination Product (y/n): N
• PMA/PMN Number: K143616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305008
• Device Lot Number: 07201509
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 DA
• Patient Weight: 82