MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 26MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number 48552426

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 08/17/2017

Event Type  malfunction  

Event Description

It was reported that; while inserting a screw, the screw head stripped and we were unable to insert or remove the screw.

Manufacturer Narrative

Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause of the event cannot be determined from the given information.

Event Description

It was reported that; while inserting a screw, the screw head stripped and we were unable to insert or remove the screw.

• Brand Name: OASYS 4.0 X 26MM 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: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6852868
• MDR Text Key: 85747511
• Report Number: 0009617544-2017-00353
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371829
• UDI-Public: (01)04546540371829
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48552426
• Device Catalogue Number: 48552426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• 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