MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS TI CANNULATED X-TAB POLY SCREW, 7.0MM X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186770040

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 04/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the information provided, it is indicated that the screw may not have been correctly placed during the primary procedure.Following the primary procedure this was discovered and hence the revision surgery.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of right l5 screw performed (b)(6) 2017 at (b)(6) hospital.Primary implant (b)(6) 2017.Following the primary procedure, it was discovered that the right l5 screw was not placed in the pedicle.It was sitting laterally and had fractured the right transverse process of l5.The screw was subsequently removed and replaced with 186750040 x 1 - 5x40mm x-tab screw, which the surgeon obtained solid purchase in the pedicle as planned.The construct was then completed with a rod, set screws and then final tightened.Ae to patient screw had to be revised, therefore a second procedure.This case is not being reported by the customer, but jjm employee.All available information has been provided as part of this report; no further information will be forthcoming.

• Brand Name: MIS TI CANNULATED X-TAB POLY SCREW, 7.0MM X 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6546519
• MDR Text Key: 74473025
• Report Number: 1526439-2017-10335
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 186770040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2017
• 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): Other; Required Intervention
• Patient Age: 60 YR