MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE MONARCH SPINE SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Unknown part number, udi is unavailable.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.

Event Description

We had a monarch removal case yesterday with the surgeon at the (b)(6) hospital in (b)(6).He was removing 4 screws, 2 rods and 4 set screws in total.Everything was removed successfully except for one screw which seemed to be the source of pain for the patient.The surgeon attempted to put a rod back in and ¿helicopter¿ the screw out, he also attempted to use a number of broken screw trauma kits to the remove the screw.This went on for the best part of 2 hours with no success, and eventually had to close the patient with the one screw remaining.

• Brand Name: MONARCH SPINE SYSTEM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL 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-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6808414
• MDR Text Key: 83193434
• Report Number: 1526439-2017-10697
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention