MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number 48558312

Device Problems Disassembly (1168); Disconnection (1171)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/12/2017

Event Type  Injury  

Event Description

It was reported that; doctor had to remove post cervical screw right c3 lateral mass screw.After looking at xrays the images revealed that the rod and screw disassociated.Doctor removed set screw and then removed the lateral mass screw.While attempting to remove the tulip popped off of the shaft.Doctor then used instrument to back out shaft and cut the rod above right c4 screw.Doctor checked other screws to confirm set screws were tightened sufficiently.This was noticed by surgeon's pa, the patient was complaining of squeaking sounds in neck.This was from a prior surgery date is unknown, thought it was end (b)(6).

Manufacturer Narrative

Method: visual inspection, device history review, complaint history review, risk assessment.Result: the tulip was confirmed to be separated from the screw shank via visual inspection.Manufacturing records for this product were reviewed and no anomalies were found.There were no other occurrences for the reported product lot.The plausible root cause is tissue ingrowth of the implanted screw.

Event Description

It was reported that; doctor had to remove post cervical screw right c3 lateral mass screw.After looking at xrays the images revealed that the rod and screw disassociated.Doctor removed set screw and then removed the lateral mass screw.While attempting to remove the tulip popped off of the shaft.Doctor then used instrument to back out shaft and cut the rod above right c4 screw.Doctor checked other screws to confirm set screws were tightened sufficiently.This was noticed by surgeon's pa, the patient was complaining of squeaking sounds in neck.This was from a prior surgery date is unknown, thought it was end (b)(6) 2017.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12
• 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: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7008938
• MDR Text Key: 91310062
• Report Number: 0009617544-2017-00399
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540596314
• UDI-Public: (01)04546540596314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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 Model Number: 48558312
• Device Catalogue Number: 48558312
• Device Lot Number: 16E023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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: 73 YR