MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS MIDLINE OCCIPUT PLATE- SMALL; IMPLANT-CERVICAL PLATE

Catalog Number 48571044

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 04/21/2016

Event Type  malfunction  

Event Description

It was reported that; during surgery, the leg of the midline occiput plate broke when the surgeon was bending it.The surgeon used spare plate.

Manufacturer Narrative

Lot# 146485.Method: visual inspection; device history review; complaint history review; risk assessment.Results: the plate was found to have fractured in a bending ductile overload mode.The material was consistent with the material listed on the print.No material or manufacturing defects were found.Conclusion: it appears that the stg was followed (not bent at the angled foot) so the probable root cause is unknown.

Event Description

It was reported that; during surgery, the leg of the midline occiput plate broke when the surgeon was bending it.The surgeon used spare plate.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE- SMALL
• Type of Device: IMPLANT-CERVICAL PLATE
• 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: 5665004
• MDR Text Key: 45655901
• Report Number: 0009617544-2016-00196
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48571044
• Device Lot Number: 146485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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