MAUDE Adverse Event Report: DEPUY SYNTHES SPINE THREE LEVEL PLATE, 51MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186803051

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Surgeon performed an acdf from c4-c7 using iliac wedge allograft surgeon placed skyline plate and freehand burred a hole for the scr;ew; surgeon used constrained self drilling screw and put them in freehand without drilling or using a guide; surgeon locked plate using normal technique; both c7 screws backed out past cam lock post-op; revision surgery not scheduled yet.

Manufacturer Narrative

(b)(4).One (1) 51mm hybrid three level plate (product code: 1868-03-051, lot number: apmc6v) was returned to the chu on (b)(6) 2016 after the initial closure of the complaint.The returned plate features heavy signs of use in terms of residue on its surface, wear to the drive features of its cams, and superficial surface damage.Most importantly, six of the eight cams show some sign of the metal on its side being compressed.This may have occurred if the screws were not fully tightened into the bone.The cams would come in contact with the side of the exposed screws when rotating the cams, applying enough force on the side of the cams in order to damage the side of the cam as opposed to closing them over the screws.This may have resulted in the screws being left to back out postoperatively.The dhr review identified issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: THREE LEVEL PLATE, 51MM
• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5500453
• MDR Text Key: 40325811
• Report Number: 1526439-2016-10212
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052552
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186803051
• Device Lot Number: APMC6V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR