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

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

Patient Problems Failure of Implant (1924); Neuropathy (1983); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/screw construct/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.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: ka-ho t, et al.(2014), locking plate for ao type c intra-articular distal radius fracture: volar or dorsal approach, journal of orthopaedics, trauma and rehabilitation, volume 18, page 83-88 (hong kong) there is controversy over the outcomes and complications of volar and dorsal plating for the treatment of intra-articular fracture distal radius.This study aims at throwing more light on this by evaluating the clinical and radiological outcomes on patients with ao type c intra-articular fracture of the distal radius treated operatively via either volar or dorsal approaches.From 2008 to 2010, 81 patients with ao type c intra-articular distal radius fractures treated with dorsal or volar plating were included in the study.50 patients were male and 31 patients were female with a mean age of 49.2 years.Among them, 39 patients were treated via volar the approach by applying either an unknown synthes 2.4-mm fixed angle locking compression plate or an unknown synthes or 3.5-mm fixed angle locking compression plate depending on the size of fragments and feasibility.42 patients were treated via the dorsal approach using an unknown synthes 2.4-mm two-column fixed angle locking compression plate.Postoperatively, the patients were allowed to have free active mobilization of their fingers and wrist.Stitches were taken off on postoperative days 10 to 14.The patients then started to have physiotherapy and/or occupational therapy until they reached maximal medical improvement.Complications were reported as follows: (volar group) 4 patients had hypertrophic scar.3 patients had median neuropathy and they were treated successfully with conservative management.1 patient had intra-articular screw penetration requiring removal of the implant.1 patient had an early loss of reduction 2 months postoperatively.1 patient had an ulna impaction with positive ulna variance of 4.3 mm.Ulna shortening osteotomy was done after the fracture had healed with good improvement of ulna wrist pain and range of movement.(dorsal group) 1 patient had hypertrophic scar.2 patients had median neuropathy.2 patients had reflex sympathetic dystrophy.2 patients had delayed extensor pollicis longus rupture.An extensor indicis tendon transfer was done in 1 patient and the other patient was treated conservatively.1 patient had rotational stiffness.This patient had sauve kapandji procedure done later.This is report 2 of 4 for (b)(4).This report is for an unknown synthes 2.4-mm fixed angle locking compression plate, unknown synthes or 3.5-mm fixed angle locking compression plate, unknown synthes 2.4-mm two-column fixed angle locking compression plate, and unknown synthes screws.(unknown plate/screw construct).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10476229
• MDR Text Key: 212377223
• Report Number: 8030965-2020-06508
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 08/06/2020
• 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