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

Model Number	188319320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6912134
• Report Number: 1526439-2017-10796
• Device Sequence Number: 10920888
• Product Code: NKG
• UDI-Device Identifier: 10705034157658
• UDI-Public: (01)10705034157658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 188319320
• Device Catalogue Number: 188319320
• Device Lot Number: APFCWP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1
• Patient Age: 34 YR