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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: DISTAL RADIUS PLATE, FIXATION ,BONE Back to Search Results
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).

 
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Brand NameUNK - PLATES: DISTAL RADIUS
Type of DevicePLATE, 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 Key10456931
MDR Text Key213025853
Report Number8030965-2020-06277
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeLO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
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 Received08/26/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/26/2020 Patient Sequence Number: 1
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