MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS VITALLIUM ROD D3.5 LG 240; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48553240
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; 2 vitallium rods broke.Patient required a revision surgery.
Additional Manufacturer Narrative
Method: risk assessment; results: no lot # was provided, so a manufacturing record review could not be performed.Device inspection, device history review, complaint history, could not be performed because the device was not returned.Conclusion: no further investigation for this event is possible at this time as no device was received by stryker.
Event or Problem Description
It was reported that 2 vitallium rods broke.Patient required a revision surgery.

• Brand Name: OASYS VITALLIUM ROD D3.5 LG 240
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5912535
• Report Number: 0009617544-2016-00353
• Device Sequence Number: 588405
• Product Code: KWP
• UDI-Device Identifier: 04546540604910
• UDI-Public: (01)04546540604910
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 48553240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention