MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X6DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 48954106

Device Problem Fracture (1260)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that a tritanium pl cage and a xia ct polyaxial cortical screw, implanted at l5-s1, fractured post-operatively.Fusion was not achieved.Revision surgery will occur to replace devices.This report captures the cage.

Event Description

It was reported that a tritanium pl cage and a xia ct polyaxial cortical screw, implanted at l5-s1, fractured post-operatively.Fusion was not achieved.Revision surgery will occur to replace devices.This report captures the cage.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, an x-ray was provided showing the fractured screw and cage.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From the tritanium ifu and stg: "the tritanium pl cages are to be used with supplemental fixation that is intended for use in the lumbosacral spine.If pedicle screws were not inserted earlier in the procedure, insert pedicle screws at this point or other appropriate supplemental fixation.Compression of the pedicle screws or interspinous device may be used to create segmental lordosis of the segment fused.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 or trauma, and that the device may need to be replaced in the future.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.Patients who smoke have been shown to have an increased incidence of non-unions.Such patients should be advised of this fact and warned of the potential consequences.Delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) must be revised or removed immediately before serious injury occurs;" the patient had normal post op activity and did not fall.The bone quality is unknown.The patient did not fuse after a year.No further patient information is available.No complications were reported in the initial surgery.Implant was not inserted/impacted at an angle, no cantilever force was applied, no difficulty with insertion with the mallet, normal impaction force was used, no repositioning of the implant was performed.It was reported that the patient did not fuse after 1 year of implantation.Additionally, there was a failure in the supplemental fixation which would increase the loading experienced by the tritanium cage.Most likely cause is a combination of repeated stresses and loading brought on by non-union and supplemental fixation failure.

• Brand Name: 10MM X6DEG X 9MM X 28MM
• 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: 10125234
• MDR Text Key: 194341352
• Report Number: 3004024955-2020-00008
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327117974
• UDI-Public: 07613327117974
• Combination Product (y/n): N
• PMA/PMN Number: K181014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Model Number: 48954106
• Device Catalogue Number: 48954106
• Device Lot Number: EA63
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention