MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 18MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48552318

Device Problems Break (1069); Detachment Of Device Component (1104); Disconnection (1171); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

It was reported that; surgeon struggled to back out screw after initially inserted.20min delay.Head of screw eventually broke off.Surgeon said inner head of screw stripped and screwdriver was no longer effective.

Manufacturer Narrative

Risk assessment.Manufacturing records for this product were not reviewed because no lot or parts were provided.Potential root causes may be: screw misaligned for angular insertion into bone, hard bone and screw connected too tight to screw driver.

Event Description

It was reported that; surgeon struggled to back out screw after initially inserted.20min delay.Head of screw eventually broke off.Surgeon said inner head of screw stripped and screwdriver was no longer effective.

• Brand Name: OASYS 3.5 X 18MM 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6358180
• MDR Text Key: 68603619
• Report Number: 0009617544-2017-00063
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371706
• UDI-Public: (01)04546540371706
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48552318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• 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