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

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

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date unknown.510k: this report is for an unk, plates: distal radius/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: gajdos r, bozik m, stranak p (2015), is an implant removal after dorsal plating of distal radius fracture always needed, bratisl lek listy, volume 116, page 357-362, (slovakia).The purpose of this retrospective study was to evaluate the need for an implant removal and the frequency of hardware-related complications in a group of distal radius fractures treated with dorsal double plating.From january 2007 to december 2011, 37 patients in whom distal radius fracture surgery was performed through a single dorsal approach with two low profile titanium plates during a period of 5 years were included in the study.All patients had their surgery within 3 weeks of injury.There were 26 males and 11 females, the mean age was 43.9 years (range 18¿77).All fractures were fixed with (2) unknown synthes 2.4 mm locking compression plate dorsal distal radius titanium plates.After the surgery, wrist was immobilized in a removable splint for a maximum of 6 weeks.The rehabilitation under the supervision of a physiotherapist targeted on wrist joint function followed.All patients were followed up on a regular basis for at least one year.During the follow-up period, an implant removal was indicated in case of pronounced subjective inconvenience, clinical and radiological signs of hardware-related complications.The average follow-up period was 17.1 months (range 12¿41).Complications were reported as follows: 2 patients had a superficial branch of the radial nerve dysesthesia.In 1 patient, the problem resolved completely after hardware removal and nerve release, the second patient required chronic medication because of residual neuropathic pain.1 patient had plate prominence resulting in radial wrist pain (fig.1).Metal removal was indicated.10 patients had soft tissue complications including extensor tendon irritation or limited wrist range of motion.All of them were treated with the implant removal and in case of a range of motion restriction also by the manipulation under general or peripheral block anesthesia.In 4 patients with a decreased range of motion of radio-carpal joint a hyperplastic soft tissue reaction was noticed during the removal procedure.The range of motion increased after the removal in all but one patient.The pain level decreased.1 patient had implant removal during the repair of missed tfcc lesion and not directly related to the dorsal plating.1 patient had implant removal during the median nerve release.In this patient, median nerve neuropathy occurred 3 months after the surgery.At the time of hardware removal, all plates were completely covered by the retinacular flap.Hypertrophy of the synovial tendon sheaths was present, but no tendon thinning, or fraying was observed.This report is for an unknown synthes 2.4 mm locking compression plate dorsal distal radius titanium plates and unknown synthes screws.A copy of the literature article is being submitted with this medwatch.This complaint involves three (3) devices.This is report 2 of 3 (b)(4).

• Brand Name: UNK - PLATES: DISTAL RADIUS
• 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: 10456931
• MDR Text Key: 213025853
• Report Number: 8030965-2020-06277
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 08/10/2020
• 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