MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS VITALLIUM TRANSITION ROD D6XL600 ROW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48573610

Device Problems Bent (1059); Break (1069)

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

Event Date 04/19/2015

Event Type  malfunction  

Event Description

It is reported by surgeon of the hospital that during a surgery procedure, two rods broke during bending.Replacement were available to complete the surgery.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: one oasys vitallium transition rod was confirmed visually to be fractured in the 6.0 mm diameter region.Manufacturing records were reviewed and no anomalies were found.The cause of the fracture is likely dependent on site specific loading conditions as well as the severity of the bending angle.Conclusion: the root cause is not determined and multifactorial.

Event Description

It is reported by surgeon of the hospital, that during a surgery procedure two rods broke during bending.Replacement were available to complete the surgery.

• Brand Name: OASYS VITALLIUM TRANSITION ROD D6XL600 ROW
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4887406
• MDR Text Key: 19736013
• Report Number: 0009617544-2015-00308
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

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: Other
• Device Catalogue Number: 48573610
• Device Lot Number: K8A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• 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