MAUDE Adverse Event Report: DEPUY SPINE INC MNTR LS SCREW 3.5X30; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	188320330
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
Head polyaxial screw disconnected from screw body.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number was not provided.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MNTR LS SCREW 3.5X30
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7306388
• Report Number: 1526439-2018-50192
• Device Sequence Number: 957867
• Product Code: NKG
• UDI-Device Identifier: 10705034158136
• UDI-Public: 10705034158136
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 188320330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1