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

Model Number 188319320

Device Problem Break (1069)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/05/2017

Event Type  malfunction  

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 for evaluation.

Event Description

On (b)(6) 2015, surgery for cervical spine trauma was performed using the mountaineer system.The fixed area was c4 - c6.Because of better bone growth, on (b)(6) 2017, removal surgery was performed due to synostosis.During the surgery, the surgeon took the following procedures.When he removed two set screws on the left side, it was confirmed that the head part of the screw (part #: 188319320, lot#: apfcwp) at c6 was loosened.Then, as he removed the rod, he noticed that the neck of this screw was broken.He tried to remove this screw shaft, however, he could not do that.Finally, he closed an incision with the broken screw shaft left in the bone.The surgery was completed without any delay.The surgeon comments that it does not matter if the broken screw shaft is left in the bone.

• Brand Name: MOUNTAINEER
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW 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: 6912134
• MDR Text Key: 88227860
• Report Number: 1526439-2017-10796
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034157658
• UDI-Public: (01)10705034157658
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041203
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 188319320
• Device Catalogue Number: 188319320
• Device Lot Number: APFCWP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR