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

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

Patient Problem Osteolysis (2377)

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.This report is for unknown plate.Pma/510(k) number is not available.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: r.Nadarajah, j.Mahaluxmivala, a.Amin, d.W.Goodier (2005).Clavicular hook-plate: complications of retaining the implant.International journal of the care of the injured.Page 681-683.((b)(6)).The present article reports a case of a clavicular fracture at the medial end of a retained implant following a low energy fall.A (b)(6) right-handed manual laborer was involved in a medium velocity road traffic accident where he was thrown off his motorbike and landed heavily on his right arm and shoulder.The patient presented with a closed grade v (rock-wood and green) acromioclavicular joint dislocation with no associated neurovascular deficit.The patient opted for surgical stabilization with a hook-plate device.No attempt was made to repair the coracoclavicular or acromioclavicular ligaments.There were no peri-operative complications and the patient was discharged home 2 days later.A year after the patient's initial injury, the patient represented with a closed fracture of the clavicle at the medial end of the plate as seen in figure 1 after a low-velocity fall from his bicycle landing directly on to his right shoulder.The patient then underwent removal of the hook plate.A contoured, narrow 9-hole dcp plate was used to stabilize the fracture and this was supplemented with ipsilateral iliac crest bone graft at the fracture site to promote bony healing (figure 2).Post-operative radiographs (figure 2) show considerable osteolysis around the joint.This report is for unknown clavicle hook plate.This is report 2 of 3 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8230838
• MDR Text Key: 132494223
• Report Number: 8030965-2019-59640
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2018

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2018
• 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: 26 YR