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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Discomfort (2330); No Code Available (3191)
Event Date 10/27/2013
Event Type  Injury  
Manufacturer Narrative
This report is for unknown synthes variable angle locking compression plate (va-lcp) anterior clavicle plate/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: van olden, g.,va-lcp anterior clavicle plate: the anatomically recontoured fixation system with angular stability for clavicle shaft, musculoskeletal surgery december 2014, volume 98, issue 3, pages 217¿223 (netherlands).The aim of this investigation was to evaluate the introduction of the va-lcp anterior clavicle plate in the treatment of clavicle fractures.Between march 2011 and march 2013, 42 patients underwent open reduction and plating for middle-third, lateral fractures or painful nonunion of the clavicle.Of the total patient group, 36/42 patients were men and 6 were women.Patient age ranged from 16 to 81 years.The synthes variable angle locking compression plate (va-lcp) anterior clavicle plate was inserted in all cases.After 1 week, the patients were seen in the outpatient clinic.Patients were seen at 6 and 24 weeks.A clinical evaluations and radiographic outcomes were then assessed.The clinical evaluation gave a mean constant score of 94 (range 53¿100) points at 6 weeks and 97 (range 81¿100) at 24 weeks.In one patient, a (b)(6) male, the placement of the lateral screw perforated the acromioclavicular joint.The implant was removed after 1 year.This patient did not have any further clinical complications.Four patients underwent elective implant removal for irritation after fracture healing and aside from the patient with the screw perforation, they include: a (b)(6) male, a (b)(6) male, a (b)(6) male.These three patients had discomfort on the medial side where the plate was not parallel to the bone.A (b)(6) female patient had a low grade wound infection.After operative wound cleaning and antibiotics, the wound healed properly.One unidentified patient had a refracture after a new trauma.This fracture healed after conservative treatment, and the hardware stayed in place.One unidentified patient, operated for a painful nonunion, had a partial neuropraxia of the nervus radialis with dropping hand.This healed completely after 12 weeks.In some cases, the va-lcp anterior clavicle plate did not bend perfectly.In one case, it was lateral to low and in another case, it was too high.In both cases, there were no clinical consequences.This report is for (b)(6) male who had implant removal due to discomfort and irritation.This report is for unknown synthes variable angle locking compression plate (va-lcp) anterior clavicle plate.This is report 6 of 11 for (b)(4).
 
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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 Key8237369
MDR Text Key132830776
Report Number8030965-2019-59759
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/03/2019
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 01/03/2019
Initial Date FDA Received01/10/2019
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;
Patient Age36 YR
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