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 Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A total of 90 patients (41 male and 49 female) with a mean age of 44 years were included in the study.This report is for an unknown low-profile titanium fixed angle palmar t-shaped plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: rampoldi, m.And marsico, s.(2007), complications of volar plating of distal radius fractures, acta orthopaedica belgica, vol, 73 (6), pages 714-719 (italy).The aim of this retrospective study is to identify possible problems and pitfalls that may generate complications, in order to reduce their incidence and severity.Between may 2002 to october 2005, a total of 90 patients (41 male and 49 female) with a mean age of 44 years were included in the study.Surgery was performed using a low profile titanium fixed angle palmar t-shaped plate (synthes ltd).Patients were followed for at least one year.The following complications were reported as follows: a (b)(6)-year-old male patient had a rupture of both extensor indicis tendons (eip and eic) 6 months after operation.At that time, the patient started complaining of a weak and incomplete extension of his index finger, which developed several days after swelling appeared on the dorsal aspect of the wrist.At surgery an extended tenosynovitis of the fourth dorsal compartment was noted, with degenerative changes and rupture of eic and eip; tenodesis of the ruptured tendons on the extensor communis tendon of the 3rd finger was done after tenosynovectomy.Radiographs showed an excessive length of one or more screws of the distal branch of the plate, with dorsal protrusion of their tips and the plate was removed.Additional complications are captured on related complaint (b)(4).This report is for an unknown low-profile titanium fixed angle palmar t-shaped plate.This is report 5 of 10 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8889215
• MDR Text Key: 154405277
• Report Number: 8030965-2019-67166
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/13/2019
• 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
• Patient Age: 42 YR