MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Necrosis (1971); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: lcp/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang x, wang s, et al.(2021), antibiotic cement plate composite structure internal fixation after debridement of bone infection, scientific reports, volume 11:16921, pages 1-6, (china).An internal fixation composite structure of antibiotic cement plates was created.The aim of this study was to analyze the infection control effect of this structure when applied to treat a bone infection.Between january 2013 and june 2019, 548 patients diagnosed with bone infection and treated with antibiotic cement plate composite structure internal fixation after debridement were included in the study.There were 418 men and 130 women with an average age of 40.35 ± 14.96 (4¿73) years.The infection sites included 309 tibias, 207 femurs, 16 radii and ulnae, 13 humeri, and 3 clavicles.The internal fixation was using the unknown synthes locking compression plate and the bone defects were filled with a competitor¿s antibiotic cement and wrapped in the plates.Antibiotics were administered intravenously for 2 weeks based on bacterial isolation.Third generation cephalosporins (ceftazidime or ceftriaxone) were routinely used before the bacterial culture results were obtained, and for those with negative results, negative pressure drainage was left in place for 10¿12 days.Complications were reported: 92 patients had relapsed of infection after a single operation after more than 6 months of follow-up.89 relapsed patients underwent a second debridement and 60 had bacteria isolated.The most common bacterial species was staphylococcus aureus in 17 patients.19 patients had the same bacterial species isolated as in the first debridement.The infection was controlled in 63 cases, and the remaining 26 cases received a third surgical debridement.6 cases had infection recurrence and 4 cases were controlled after debridement at 12 months follow-up.7 patients remained persistently infected, and 6 underwent amputation.8 patients had epidermal necrosis around the incision.6 patients had fixation failure.30 patients had lower extremity swelling.This is for the unknown synthes locking compression plate.This report is for (1) unk - constructs: lcp.(b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12610491
• MDR Text Key: 282391025
• Report Number: 8030965-2021-08598
• 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: foreign,literature
• Type of Report: Initial
• Report Date: 09/13/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention