MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MNTR H/H X-CONN OUTER NUT; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188341100
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
(b)(6).On (b)(6) 2017, surgery was performed using the mountaineer system.Expedium head-to-head cross connector was placed to fix c2-c3.In (b)(6) 2017 after the patient left the hospital, no loosening of the outer nut was confirmed through an x-ray.In (b)(6) 2017, however, it was confirmed that the outer nut (part#: 188341100, lot#: unknown) completely come off on its right side.Surgical re-operation is not scheduled so far.

• Brand Name: MNTR H/H X-CONN OUTER NUT
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7105798
• Report Number: 1526439-2017-50056
• Device Sequence Number: 16426884
• Product Code: NKG
• UDI-Device Identifier: 10705034158662
• UDI-Public: 10705034158662
• Combination Product (Y/N): N
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: Health Professional
• Device Catalogue Number: 188341100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 61 YR