MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK_SPN

Device Problems Bent (1059); Loose or Intermittent Connection (1371); Material Deformation (2976)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/14/2018

Event Type  Injury  

Event Description

It was reported by a physician that a patient had an aviator cervical plate implanted by another neurosurgeon.One of the screws on x-ray began to project out and after seeing patient for a second opinion, he wanted to remove the screws and plate.When surgeon exposed the plate and screws, it was indicated that both of the lower screws had began to loosen and project out, and the wings of the locking plate were bent.

Event Description

It was reported by a physician that a patient had an aviator cervical plate implanted by another neurosurgeon.One of the screws on x-ray began to project out and after seeing patient for a second opinion, he wanted to remove the screws and plate.When surgeon exposed the plate and screws, it was indicated that both of the lower screws had began to loosen and project out, and the wings of the locking plate were bent.

Manufacturer Narrative

Method: labelling review, risk assessment.Result: the plate was confirmed by the surgeon to have a deformed locking mechanism post op.A revision surgery has occurred and the explants were not returned.Manufacturing files were not reviewed because no lot numbers were provided.The surgeon reported that the patient had not fused.Conclusion: the probable root cause is patient non-union (fusion) as per the 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 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 advice 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.".

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7560453
• MDR Text Key: 109775368
• Report Number: 0009617544-2018-00119
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

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
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR