MAUDE Adverse Event Report: SYNTHES MONUMENT 2.0MM CORTEX SCREW SELF-TAPPING 12MM; SCREW, FIXATION, BONE

Catalog Number VS202.012

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device is a veterinary product.No patient information will be reported.Date infection began is not known.Udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 Description

This report is for a veterinary case.There was no human patient involvement.It is reported patient underwent a right tibial plateau leveling osteotomy (tplo) procedure on (b)(6) 2017.Initial surgery went well with no reported issues.Patient was returned to emergency hospital with fever of 105 degrees and loss of appetite on (b)(6) 2017.Bloodwork and x-rays taken that day revealed the bone was healed but an infection in the bone at the implant site was noted.Antibiotics and fluids reduced the fever, only to have the fever recur again on (b)(6) 2017.Patient was returned to surgery on (b)(6) 2017 where surgeon removed all hardware intact.A culture was done on (b)(6) 2017 to determine the correct course of antibiotic needed.Surgeon also noted the entire leg is infected, including the tibia and femur.Patient was discharged from the facility on (b)(6) 2017 with a prescription of tramadol and an appetite stimulant as the patient would not eat on their own.On (b)(6), the patient was re-admitted to the hospital with a fever, suspected pancreatitis, and swollen lymph nodes.Due to lack of appetite, patient was placed on a feeding tube for forty-eight hours.A biopsy has been scheduled to address swollen lymph nodes.Patient is canine.This report is for one (1) 2.0mm self-tapping cortex screw.This is report 5 of 6 for (b)(4).

• Brand Name: 2.0MM CORTEX SCREW SELF-TAPPING 12MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6599732
• MDR Text Key: 76245350
• Report Number: 1719045-2017-10518
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS202.012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1