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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 Unspecified Infection (1930); Nerve Damage (1979); Skin Irritation (2076); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pma/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.(b)(4).
 
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: chen, acy, cheng cy, weng cj, chou yc (2019), intramedullary nailing and plating osteosynthesis in the correction of posttraumatic deformity in late-diagnosed distal radius fractures: a retrospective comparison study, bmc musculoskeletal disorders, volume 20, pages 1-8, (taiwan).The aim of this retrospective study was to describe our experience using open osteotomy, local bone grafting, and fracture stabilization with two different devices for treatment of posttraumatic deformity in late-diagnosed fractures of the distal radius.Between 2006 and 2014, 47 patients (47 fractures) who underwent surgical reduction and internal fixation for unilateral distal radius fracture with completion of at least 2 years follow-up were included in the study.The patients were divided into 2 groups based on the types of internal fixation.There were 2 types of implants including intramedullary nail in 22 patients (group a) and locking plate in 25 patients (group b).In group a, there were 14 females and 8 males with an average age of 59.1 +/- 10.9 years (range 32¿81) and they were all implanted with a competitor¿s intramedullary nail.Meanwhile, in group b, there were 11 females and 14 males with an average age of 50.4 +/- 17.8 years (range 20¿78) and they were all implanted with an unknown synthes 2.4-mm titanium juxta-articular volar plate.Radiographic analysis including radial height, radial inclination, and volar tilt was performed preoperatively and 2-year postoperatively.The modified mayo wrist score (mmws) was used for functional evaluation and a and a 10-point visual analog scale (vas) for residual pain assessment.Patient satisfaction was self-reported as a 5-point scale.Clinic follow-up averaged 27.7 +/- 4.7 months (range, 24 to 38) in the nail group; 28.8 +/- 4.8 months (range, 24 to 38).Complications were reported as follows: 2 patients had paresthesia over the palm.1 patient completely recovered while the other did not.2 patients had a superficial infection which resolved after oral antibiotic treatment.6 patients had implant removal due to hardware irritation.3 patients had implant removal due to screw migration.This report is for an unknown synthes 2.4-mm titanium juxta-articular volar plate and unknown synthes screws.This complaint involves three (3) devices.This report is for (1) mmsi driver shaft for red screw.This is report 1 of 3 (b)(4).
 
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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 Key10472292
MDR Text Key205472639
Report Number8030965-2020-06488
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial
Report Date 08/05/2020
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 08/05/2020
Initial Date FDA Received08/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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