MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number 48552314

Device Problems Mechanical Problem (1384); Difficult To Position (1467); Malposition of Device (2616)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 08/02/2016

Event Type  Injury  

Event Description

It was reported that an angle screw placed in cervical spine, rod placed on construct, blocker placed, final tightened.X-ray taken, surgeon was unhappy with the screw, therefore wanted to reposition it.The screw was no longer polyaxial and fixed in position, screwdriver unable to engage with screw, or poly adjustment driver.Therefore screw had to be turned and pulled out, damage to joint of cervical bone.Screw inspected by rep, it appears the shank of the screw has been pushed down and almost popped through the tulip head, therefore fixed in position.

Manufacturer Narrative

Device history review; complaint history review; risk assessment; the patient had a cancer of the neck, with a tracheostomy, he had a poor prognosis due to his cancer, bone was a bit softer where the disease has infiltrated the vertebral bodies, but there was a good old on the screws.Manufacturing records for this product were reviewed and no incidents were found.The probable root cause is due to patient pathology.

Event Description

It was reported that an angle screw placed in cervical spine, rod placed on construct, blocker placed, final tightened.X-ray taken, surgeon was unhappy with the screw, therefore wanted to reposition it.The screw was no longer polyaxial and fixed in position, screwdriver unable to engage with screw, or poly adjustment driver.Therefore screw had to be turned and pulled out, damage to joint of cervical bone.Screw inspected by rep, it appears the shank of the screw has been pushed down and almost popped through the tulip head, therefore fixed in position.

• Brand Name: OASYS 3.5 X 14MM POLYAXIAL SCREW
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5884476
• MDR Text Key: 52380766
• Report Number: 0009617544-2016-00338
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371683
• UDI-Public: (01)04546540371683
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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: 48552314
• Device Lot Number: 15A707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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): Other