MAUDE Adverse Event Report: MONUMENT SYNTHES USA LLC; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.617.707S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930); Nerve Damage (1979); Renal Impairment (4499)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, patient underwent an anterior cervical discectomy and fusion surgery.Followed by an incision and drainage procedure on (b)(6) 2024.The surgery resulted in a carbapenem-resistant pseudomonas aeruginosa spinal infection, osteomyelitis, abscess formation, phlegmon with nerve root involvement, acute kidney injury, bilateral lung collapse, and additional injuries.
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.H11 additional narrative: corrected: g1 manufacturer site.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary = > 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 history lot manufacturing location: brandywine / packaged, sterilized and released by: monument manufacturing date: 03-nov-2023.Expiration date: 30-sept-2028.Part number: 04.617.707s, zero-p natural plate size 7 with assembly tool-sterile.Lot number: 8307p85 (sterile).Lot quantity: 20.Device history review.A manufacturing record evaluation was performed for the finished device with batch number 8307p85.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MONUMENT SYNTHES USA LLC; 1200 synthes avenue; monument CO 80132
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1301 goshen parkway; west chester PA 19380
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24778013
• Report Number: 1719045-2026-00004
• Device Sequence Number: 14986045
• Product Code: KWQ
• UDI-Device Identifier: 10705034811673
• UDI-Public: (01)10705034811673(17)280930(10)8307P85
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.617.707S
• Device Lot Number: 8307P85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female