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

Catalog Number 48552314

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/05/2016

Event Type  Injury  

Event Description

It was reported that; surgeon could not advance or back out screw after initially being inserted.Surgeon used polyaxial driver then used screwdriver and could not adjust screw.Had to helicopter screw out twice.Update; there was over an hour surgical delay to helicopter out screws then re insert them.(2x).

Manufacturer Narrative

Device inspection, device history review, and complaint history review could not be performed, as the device was not returned and a valid lot code could not be obtained.The root cause is undetermined.

Event Description

It was reported that; surgeon could not advance or back out screw after initially being inserted.Surgeon used polyaxial driver then used screwdriver and could not adjust screw.Had to helicopter screw out twice.Update; there was over an hour surgical delay to helicopter out screws then re insert them.(2x).

• 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: 5829177
• MDR Text Key: 50645283
• Report Number: 0009617544-2016-00308
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371683
• UDI-Public: (01)04546540371683
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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