MAUDE Adverse Event Report: DEPUY SPINE INC COCR DD ROD 3.5-5.5 X 600; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	188310012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp.(b)(6).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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
It was reported that the cocr dd rod 3.5-5.5 x 600 was broken during reverse logistics audit of returned device at millstone.There was no patient involvement, and no additional information is available.This report is for a cocr dd rod 3.5-5.5 x 600.This is report 1 of 1 for (b)(4).

• Brand Name: COCR DD ROD 3.5-5.5 X 600
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12816510
• Report Number: 1526439-2021-02417
• Device Sequence Number: 20028279
• Product Code: NKG
• UDI-Device Identifier: 10705034290331
• UDI-Public: (01)10705034290331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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 Model Number: 188310012
• Device Catalogue Number: 188310012
• Device Lot Number: TBHGV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown