MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; PLATE, FIXATION, BONE

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between february 2000 and june 2014.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.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: vicentia g., et al (2019), comparison of plate, calcaneoplasty and external fixation in the management of calcaneal fractures, injury, int.J.Care injured, pages 1-8 (italy).This retrospective study aims to compare and identify the surgical technique with the best outcomes for the treatment of intra-articular calcaneal fractures.Between february 2000 and june 2014, a total of 206 patients were treated with one of the following techniques: open reduction and internal fixation with screws and plate; percutaneous reduction and monolateral external fixation; and balloon-assisted reduction, pin fixation and tricalcium phosphate augmentation.Out of these, 58 patients (27 male and 31 female) with a mean age of 56.5± 4.3 years were treated by lateral access with a low-profile plate (synthes calcaneal locking plate) and screws.All patients were routinely followed up at 6 weeks, 3, 6 and 12 months after operation and then yearly with standard radiographs, while a ct scan was performed only in the immediate postoperative period to evaluate length, width, height, subtalar joint congruency patients, were followed up for a mean of 10 years and 5 months (range 6¿16 years).The following complications were reported: 3 patients suffered from wound dehiscence and skin necrosis.1 patient had a reflex sympathetic dystrophy.1 patient had an osteomyelitis.1 patient had sural nerve lesion.The plate and screw were removed in ten patients (17%).This report is for an unknown synthes low-profile plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8864617
• MDR Text Key: 153392325
• Report Number: 8030965-2019-66878
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2019
• 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