MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MOUNTAINEER LS SCREW 3.5X26; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188320326

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/23/2014

Event Type  Injury  

Event Description

International affiliate reports c1/2 fusion was performed using harm¿s technique.Original surgery was performed on (b)(6) 2014.Revision surgery was performed on (b)(6) 2014 to reposition the mountaineer ls screw as it was slightly into the oc joint.The screw was not removed from the patient but was repositioned.No further information available.It is not known how/why the screw became positioned in the oc joint.

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.Device remains implanted.

• Brand Name: MOUNTAINEER LS SCREW 3.5X26
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4262006
• MDR Text Key: 5005760
• Report Number: 1526439-2014-12099
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK041203
• 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: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 188320326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2014
• 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