MAUDE Adverse Event Report: DEPUY SPINE INC CORTICAL FIX X-TAB 6X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186760140
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was scheduled for a revision surgery on (b)(6) 2021 due to screw head come off.Originally, the patient had primary spinal fusion at 3a-3b (treating thoracic myelopathy after decompression) on (b)(6) 2021.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) cortical fix x-tab 6x40mm ti.This report is 2 of 4 for (b)(4).

• Brand Name: CORTICAL FIX X-TAB 6X40MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12242815
• Report Number: 1526439-2021-01555
• Device Sequence Number: 3531577
• Product Code: NKB
• UDI-Device Identifier: 10705034465456
• UDI-Public: 10705034465456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186760140
• Device Catalogue Number: 186760140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention