MAUDE Adverse Event Report: DEPUY SPINE INC MNTR OC INNER SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	188362025
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2022.Additional procodes: hrs, hwc, kwp.Date of concomitant therapy is (b)(6) 2022.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.(b)(4).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 patient underwent revision surgery of a posterior spinal fusion on (b)(6) 2022.The original procedure was done on (b)(6) 2022.On an unknown date following the initial procedure, the mountaineer oc plate, two (2) rods, and two (2) set screws popped out.Both rods popped out but were still in the cervical portion.It was noted that the patient did not wear a neck brace all the time and the neck may have been hyperextended in the original case.The doctor had only put two screws on the plate.The angle was bad, and the third screw could not be added.Patient was revised to an occipital to t2 fusion.In the revision, the surgeon put in all three screws.This report is for a mountaineer occipital screw.This is report 4 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the photo.Visual analysis of the photo revealed that the mntr oc inner screw device was not migrated from the position that it was previously implanted, since it was still in the mntr oc plate small device, therefore, the allegation reported cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the mntr oc inner screw.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: MNTR OC INNER SCREW
• 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: 13712052
• Report Number: 1526439-2022-00362
• Device Sequence Number: 15024503
• Product Code: NKG
• UDI-Device Identifier: 10705034158853
• UDI-Public: (01)10705034158853
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 188362025
• Device Catalogue Number: 188362025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MNTR OC INNER SCREW; MNTR OC PLATE SMALL; OC ADJ ROD LOPRO 3.5 X 120 - 7; OC ADJ ROD LOPRO 3.5 X 120 - 7; UNK - SCREWS: MOUNTAINEER OCT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 41 KG