MAUDE Adverse Event Report: DEPUY SPINE INC EXP TI CP ROD, 300 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179777300
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
Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; 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 on (b)(6) 2021, the rods were broken during reverse logistics audit of returned device at (b)(4).There was no patient involvement, and no additional information is available.This complaint involves five (5) number of devices.This report is for (1) exp ti cp rod, 300 mm.This is report 3 of 5 for complaint (b)(4).

• Brand Name: EXP TI CP ROD, 300 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 12848056
• Report Number: 1526439-2021-02443
• Device Sequence Number: 14511221
• Product Code: NKB
• UDI-Device Identifier: 10705034078434
• UDI-Public: 10705034078434
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 179777300
• Device Catalogue Number: 179777300
• Device Lot Number: PD7079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 300 MM; ROD, 300 MM; ROD, 480 MM; ROD, 480 MM
• Patient Sex: Unknown