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 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).

• 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: 10472292
• MDR Text Key: 205472639
• Report Number: 8030965-2020-06488
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/05/2020

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 Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention