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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: meda, pvk.Et al (2006), "clavicular hook plate for lateral end fractures-a prospective study, injury." international journal of the care of the injured, vol.37(3), pages 277-283 (united kingdom).This prospective study aims to evaluate the use of the clavicular hook plate as a method of treatment in displaced fractures of the lateral third clavicle.Between 1998 and 2002, a total of 31 patients (24 male and 7 female) with a mean age of 49 years (range, 25-86 years) were included in the study.The patients were divided into 2 groups: an acute group consisted of 23 patients (16 patients with type ii fractures and 7 patients with type iii fractures) who were operated on within 2 weeks while delayed group consisted of 8 patients (5 patients with type ii fractures and 3 patients with type iii fractures) who were operated on after 4 weeks.The hook plate used in this study is manufactured by synthes group.It comes in both stainless steel and titanium versions.The hook plate is a slightly curved dynamic compression plate which takes 3.5 mm screws with modification at the lateral end.The plates come in 2 different sizes of 6 and 8 holed plates.The hook is available in 2 depths (15 and 18 mm).Patients were followed-up every 3 months for the first 1 year and every 6 months thereafter.The mean follow-up was 40 months (range, 18-68 months).The following complications were reported as follow: a (b)(6) male underwent plate removal at 6 months due to pain.A (b)(6) female underwent plate removal at 8 months due to lucency.A (b)(6) male underwent plate removal at 3 months due to pain.A (b)(6) male underwent plate removal at 8 months due to lucency.A (b)(6) male underwent plate removal at 4 months due to pain.A (b)(6) male underwent plate removal at 4 months due to pain.A (b)(6) male underwent plate removal at 5 months due to lucency.A (b)(6) male underwent plate removal at 5 months due to lucency.A (b)(6) male underwent plate removal at 3 months due to pain.A (b)(6) male underwent plate removal at 9 months due to lucency.A (b)(6) male underwent plate removal at 3 months due to pain.2 patients had superficial infections with erythema and serous discharge, which resolved with oral antibiotics.6 patients with impingement signs and symptoms at the 3-6 months follow-up sessions.These patients became symptom free in 6 weeks of removal of the hook plate.5 patients showed a small area (5-10 mm) of radiolucency at the tip of the hook at 6 months follow-up.Plates with this appearance were removed and these patients were followed-up with serial radiographs.This report is for an unknown synthes hook plate.This is report 2 of 10 for (b)(4).The complaint involves 12 devices.Due to a limit of impacted products per complaint, this complaint will be captured under two separate complaints: (b)(4) will include 10 devices and (b)(4) will include 2 devices.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8231138
• MDR Text Key: 132510050
• Report Number: 8030965-2019-59644
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• 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: 50 YR