MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SKYLINE VARIABLE S-T SCREW, 12MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186852012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/20/2014

Event Type  Injury  

Event Description

Per international affiliate, it was reported that the surgeon revised a skyline plate patient due to infection.The patient was first operated in (b)(6) of this year and developed an infection.The surgeon had difficulty removing the plate and the orthopedic surgeon on call came in to assist.They pulled on the plate and the construct consisting of one skyline one level plate and four skyline self-drilling screws came off in one piece.A shaped vg2 allograft was added to one of the vertebrae to fill the cavity.Surgery was delayed 60 minutes and patient needed extra grafts.The following mfg.Medwatch reports are being filed for the one skyline plate and four skyline self-drilling screws that were involved in the event: 1526439-2014-11571, 1526439-2014-11572, 1526439-2014-11573, 1526439-2014-11574, 1526439-2014-11575.

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Not returned.

• Brand Name: SKYLINE VARIABLE S-T SCREW, 12MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 38 chemin blanc; lelocle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3853585
• MDR Text Key: 4409767
• Report Number: 1526439-2014-11572
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 186852012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2014
• 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
• Patient Outcome(s): Required Intervention