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

Device Problem Migration (4003)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Tachycardia (2095); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown philos plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown philos plate.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: khunda, a., stirrat, n.And dunlop, p.(2007), injury to the axillary artery, a complication of fixation using a locking plate, journal of bone and joint surgery, vol.89-b no.11, pages 1519-1521 (england) https://doi.Org/10.1302/0301-620x.89b11.19264.This study presents a case report to demonstrate the potentially serious consequences of the device cutting out of the humeral head.A (b)(6) year-old woman presented with a widely displaced fracture of the left humeral neck following a fall.Internal fixation was performed the following day, using a short philos plate held by 6 proximal and 3 distal locking screws.A radiograph taken 12 days after the operation showed that the screws had cut-out from the humeral head allowing displacement of the plate which remained attached to the humeral shaft.It was decided to undertake a revision procedure using a hemiarthroplasty.There was a tense haematoma in the deltopectoral interval and around the displaced implant.After removal of the proximal locking screws and plate there was considerable deep haemorrhage.Throughout the following evening, the swelling around the left shoulder continued to increase.Pain and tachycardia indicated continuing haemorrhage and she was therefore taken back to theatre where a vascular surgeon explored the axillary artery and placed additional stures at one of the previous sites repair.A tense haematoma, developing on the left anterior chest wall, was investigated by aortic-arch angiography.She was discharged from hospital 20 days after the last exploration.This report is for an unknown philos plate.It captures plate displacement.This is report 1 of 2 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: 8350282
• MDR Text Key: 136499396
• Report Number: 8030965-2019-61113
• 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: 01/30/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/19/2019
• 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: 67 YR