MAUDE Adverse Event Report: STRYKER CORPORATION IVAS; CEMENT, BONE, VERTEBROPLASTY

Model Number 0705115000

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2017

Event Type  malfunction  

Event Description

Outcome: unintentional retained object.Patient in room for l2 and l5 kyphoplasty.During case dr uses stryker ivas inflatable vertebral augmentation system 15.0mm.When the applicator was removed it was noticed that the end was missing.The part that was missing was the radiolucent marker that is a ring 1mm diameter made of platinum and meredium at l5.Doctor made patient aware.Rep of stryker made company aware.Anesthesia aware.Ref# 0705-115-000 lot# 17013012 exp: 01-01-2020.Complications: kyphoplasty balloon broke off and is in l5 vertebral body - spoke with rep in room and called stryker: plastic balloon and metal tip (platinum iridium) are inert, mri safe; there should be no effect from this.The patient and her husband were informed of the this.Procedural note: performed at the same level from the right side.Balloons were inserted, slowly inflated, allowed to sit for several minutes and then completely deflated.Upon removing the balloons, the left one came out, but the right one broke-off in the vertebral body.Patient has a history of compression fractures in her lumbar spine.Recently she had some new compression fractures at l2 and 5.She ended up having kyphoplasty.In the past she has done really well after kyphoplasty this time she is having little more pain in the back no pain down the legs.She is accompanied by her husband.They requested pain medication.Status post kyphoplasty 2 weeks: doing well since her surgery and discharge from the hospital.Has had significant improvement of her lower back pain and states her overall mobility is starting to improve.Continues to deny any radicular pain or paresthesias and has had no saddle numbness or bowel/bladder incontinence.Has been wearing her brace as instructed for comfort.Has not required any medication for pain control.

• Brand Name: IVAS
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 6590355
• MDR Text Key: 75942231
• Report Number: 6590355
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2020
• Device Model Number: 0705115000
• Device Catalogue Number: 0705115000
• Device Lot Number: 17013012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 56