MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CAPSTONE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number G2911026

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

This product is not approved for sale in us but a similar device with catalog # 2991026, 510k #k073291 and (b)(4) was cleared in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.However x-rays were reviewed and their results are as follows: x-ray review: "post-op ct/x-ray for l4-5 tlif (transforaminal lumbar interbody fusion) show posterior displacement of cage.Reported to have occurred after 9 years from surgery, no other films provided that show initial placement is ok.There is no bone growth in the interbody space and it looks like there is a bone remodeling in the anterior interbody space suggesting the device was not properly inserted in the original surgery.".

Event Description

It was reported that the patient underwent mis-tlif (minimally invasive surgery- transforaminal lumbar interbody) at l4/5 about 9 years ago in which the cage was implanted at l4/5 right, multi-axial screws were placed at both sides of l4 and l5 and rods were placed on both sides of l4/5.Post-op, the cage was found to back out.Neurological symptom was developed due to cage back out.No loosening of plugs or screws was reported.All implants were removed completely in a revision surgery and were replaced with competitor¿s implants.The patient issue has been resolved.

• Brand Name: CAPSTONE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6878234
• MDR Text Key: 86692742
• Report Number: 1030489-2017-02077
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: G2911026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 61