MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS CROSS CONNECTOR MEDIUM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48551074

Device Problems Difficult to Remove (1528); Failure to Disconnect (2541); Mechanics Altered (2984)

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

Event Date 07/21/2015

Event Type  malfunction  

Event Description

It was reported one side of the cross connector failed to come out of the patient.The tool fit on top but would not come off.Had to cut the connector off in the middle and unscrew the whole half piece.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no manufacturing anomalies were reported.The nut was able to be loosened from the connector and biological debris/growth was found in the threaded area.It was unknown when the implants were originally implanted according to the stryker rep.Conclusion: the probable root cause is therefore normal biological growth around the implant and no product issue was found.

Event Description

It was reported one side of the cross connector failed to come out of the patient.The tool fit on top but would not come off.Had to cut the connector off in the middle and unscrew the whole half piece.

• Brand Name: OASYS CROSS CONNECTOR MEDIUM
• 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: 5008738
• MDR Text Key: 24444841
• Report Number: 0009617544-2015-00365
• Device Sequence Number: 1
• Product Code: KWP
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48551074
• Device Lot Number: 131029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2013
• 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