MAUDE Adverse Event Report: UNK - CONSTRUCTS: VA-LCP MEDIAL COLUMN FUSION PLATES/SCREWS; PLATE,FIXATION,BONE

Catalog Number UNK - CONSTRUCTS: PLATE/SCREWS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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 being filed after the review of the following journal article: nilsen, f.A., molund, m., and hvaal, k.H.(2020), two cases of periprosthetic fracture after surgery for acute midfoot charcot, the journal of foot & ankle surgery, vol.59, pages 394-398 (norway) the aim of this report is to present 2 cases with complications to early surgery using the superconstruct technique, previously sparsely noted in the literature.The 2 cases presented are patients included in a prospective cohort, investigating the utility of the superconstruct technique for acute midfoot charcot (brodsky 1).(b)(6) a (b)(6) male patient presented at the diabetic foot clinic in april 2015 with typical charcot symptoms in his left foot.Primary x-rays showed charcot changes type 1 according to the brodsky classification and dislocation in the sagittal view of >10° break of the meary line.Magnetic resonance imaging showed an active charcot process in the naviculocuneiform joint, classified as eichenholtz stage 1 to 2.Patient underwent compression using a medial column fusion plate (depuy synthes, zuchwil, switzerland).One month after surgery, he was readmitted because of active wound infection and general infectious symptoms.Blood tests showed elevated c-reactive protein and leukocytosis.Empirical antibiotic treatment was started intravenously.The wounds were debrided, leaving the plates uncovered.Primarily the wounds were treated by vacuum-assisted wound closure (vac).At follow-up the inflammatory response had decreased and the wounds were granulating.Antibiotics were discontinued 2 months after surgery.A short time after, the patient again developed symptoms of infection, treated by serial revisions and antibiotics.X-rays taken in mid- august showed healing of all fusions, and suppressive antibiotic treatment was decided until planned plate removal.At this point, a computed tomography (ct) scan, ordered to confirm healing of the fusions before planned plate removal, showed signs of a periprosthetic fracture/fragmentation of the navicular bone (b)(6) a (b)(6) female patient had all cardinal symptoms of charcot, with redness, increased skin temperature, and swelling.X-rays showed fragmentation of the navicular bone and dislocation with 15° break of the meary angle in the sagittal view.Patient underwent a complete medial column fusion using a medial column fusion plate (depuy synthes).One month after surgery, wound necrosis was observed in the proximal end of the incision, but no uncovering of hardware, and was treated by simple debridement in the outpatient clinic and empirical antibiotics.Four months later patient once again experienced diffuse pain in the foot without any preceding trauma.X-rays showed loosening of 1 screw, and once again she was encouraged to offload in a crow.Ct follow-up showed periprosthetic fracture of collum tali at the end of the plate fixation.She was reoperated with removal of the plates, revision of her periprosthetic fracture, autologous bone transplantation, and refixation with compression screws.This report is for an unknown synthes medial column fusion plate.This is report 1 of 3 for (b)(4).

Event Description

This report is for one (1) unk - constructs: va-lcp medial column fusion plates/screws.

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: 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.B5, d1.

• Brand Name: UNK - CONSTRUCTS: VA-LCP MEDIAL COLUMN FUSION PLATES/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• MDR Report Key: 12497457
• MDR Text Key: 272216164
• Report Number: 8030965-2021-07861
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PLATE/SCREWS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/29/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR