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 Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown distal radius plates and screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: kiyoshige, y.(2002), condylar stabilizing technique with ao/asif distal radius plate for colles¿ fracture associated with osteoporosis,techniques in hand and upper extremity surgery, vil.6(4), pages 205-208 (japan).The purpose of this study is to present this technique and results of the author establishing a new reduction and fixation technique for osteoporotic distal radius fracture with a use of ao/asif volar distal radius plate, referring to the condylar plating technique in distal femoral fracture.A total of 25 female patients older than 55 years of age with a distal radial fracture and insufficient bone stock were treated with an ao/asif volar distal radius plate using a volar approach.The following complications were reported as follows: 1 patient had dorsal tendon irritation from an excessively long ulnar screw, which was treated with hardware removal.2 patients felt ulnar wrist pain in forearm rotation.They were suspected to have a class 1b tfcc injury because of an associated fracture of the ulnar styloid base.Patients are instructed to keep performing dobyns¿ six-pack exercise5 at least three times per day until hand swelling disappears.This report is for an unknown synthes ao/asif distal radius plates and screws.It captures the reported ulnar wrist pain, hand swelling.This is report 2 of 2 for (b)(4).

• 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: 10359707
• MDR Text Key: 201746921
• Report Number: 8030965-2020-05582
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/13/2020

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: 07/13/2020
• Initial Date FDA Received: 08/03/2020
• 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