MAUDE Adverse Event Report: STRYKER SPINE-US OASYS BLOCKER; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 48551000

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

It was reported that the blocker was found loose intra-op during the revision surgery.The blockers was locked securely using standard torque.No other consequence was reported to the patient.

Event Description

It was reported that the blocker was found loose intra-op during the revision surgery.The blockers was locked securely using standard torque.No other consequence was reported to the patient.

Manufacturer Narrative

Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.Manufacturing records and complaint history were not able to be reviewed because no lot was provided.The torque wrench used to tighten the blocker during implant surgery was disposed of by the physician; it is unknown if the wrench was properly working.From the surgical technique: the surgeon must discuss all physical and psychological limitations inherent to the use of the device with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion must be directed to the issues of premature weight-bearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and make the patient aware of possible adverse effects.For patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.The plausible root cause of the reported event is unknown at this time due to lack of returned explants.Possible root causes include: excessive load due to unstable construct.Excessive load due to patient anatomy/pathology.Set screws not tightened correctly.Device not returned.

• Brand Name: OASYS BLOCKER
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8349942
• MDR Text Key: 136753173
• Report Number: 0009617544-2019-00011
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (y/n): N
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48551000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR