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

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).

• 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: 8237369
• MDR Text Key: 132830776
• Report Number: 8030965-2019-59759
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• 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 Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR