MAUDE Adverse Event Report: DEPUY SPINE INC SI POLYAXL EXT TAB 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179732740
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
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.Additional device product codes: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 depuy synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2018 the patient underwent a primary procedure (l3-s) and 7.0mm (diameter) screws were applied.On an unknown date, it was found that the screw at l3 had been loose.The 2nd procedure (1st removal) was done on (b)(6) 2018 to remove the loose screw and deploy a replacing screw (10mm in diameter).Also, the fusion was extended up to l1.Screws (7 x 40mm) were applied to l1 and l2.Next, it was confirmed on an unknown date that the screws at l1 and l2 had gradually backed out, approximately a half the length of the screw at l1 had come off the lesion.The patient suffered from pressure ulcer due to this l1 backed-out screw.Furthermore, a test on the patient¿s infection measured crp15 and wbc24000.They had the patient take antibiotics and vancomycin for an upcoming removal procedure.The patient underwent another removal procedure on (b)(6) 2022.All the formerly implanted devices (12 screws, 2 rods, 12 setscrews and 2 cross-links) were removed.The l1 screw was sent for cultivation test on the patient¿s infection.The surgeon confirmed that the event had not been triggered by the implants.No further information is available.This report captures the second hardware removal procedure which was performed on (b)(6) 2022, while related complaint (b)(4) captures the first removal procedure which was performed (b)(6) 2018 due to loose screw.This report is for one (1) si polyaxl ext tab 7 x 40mm this is report 3 of 4 for complaint (b)(4).

• Brand Name: SI POLYAXL EXT TAB 7 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15204246
• Report Number: 1526439-2022-01386
• Device Sequence Number: 11279611
• Product Code: NKB
• UDI-Device Identifier: 10705034074030
• UDI-Public: (01)10705034074030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 179732740
• Device Catalogue Number: 179732740
• Device Lot Number: 188581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/10/2022
• 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: SI POLYAXL EXT TAB 7 X 40MM; SI POLYAXL EXT TAB 7 X 40MM; SI POLYAXL EXT TAB 7 X 40MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male