MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information received, the root cause could not be determined.

Event Description

(report 19 of 19) in the article "comparison of the radiographic and clinical outcomes between the sinus tarsi and extended lateral approaches for intra-articular calcaneal fractures: a retrospective study" by mao et el., the aim of the author's study was to compare the radiological and functional outcomes of the extended lateral and sinus tarsi approaches for managing displaced intraarticular calcaneal fractures.This was a retrospective study that involved 44 patients with displaced intra-articular calcaneal fractures.The patients were treated with either the extended lateral or sinus tarsi approach (ela and sta respectively) and followed up for at least a year.The radiological and clinical outcomes were compared between the approaches.According to the authors, between january 2018 and january 2020, 44 patients with displaced intra-articular calcaneal fractures (sanders types ii and iii) were treated by two experienced surgeons at a level-1 trauma center.Each of the two surgeons performed the ela and sta separately.All patients were 18-65 years old; they had sustained injuries from falls or motor-vehicle accidents and had undergone open reduction and internal fixation with either the ela or sta.The patients were placed in the lateral decubitus position under spinal anesthesia using a tourniquet.In both groups (ela and sta), all patients were administered prophylactic antibiotic therapy with first-generation cephalosporin, both preoperatively and postoperatively; the postoperative course comprised three doses spaced 8 hours apart.In both the ela and sta groups, locking calcaneal plates (acumed combo calcaneal plates) were used for fixation.The following complications were reported: - 8 patients with subtalar arthrosis -8 patients with superficial infection.These patients required antibiotic treatment and wound care.-3 patient with deep infection.These patients underwent debridement for infection control.I was reported there was no need for implant removal.There are 19 related report numbers for this event 3025141-2024-00313 through 3025141-2024-00331.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro 97124
• MDR Report Key: 19140393
• MDR Text Key: 340562342
• Report Number: 3025141-2024-00331
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other