MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE

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

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown quantity of unknown philos screws/unknown lot.Part and lot number are unknown; udi 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: erasmo, r., guerra, g., and guerra, l.(2014), fractures and fracture-dislocations of the proximal humerus: a retrospective analysis of 82 cases treated with philos locking plate, injury, international journal of the care of the injured, vol.45s, pages s43-s48 (italy).The purpose of this study was to present a retrospective evaluation of the clinical outcome of 82 consecutive fractures and fracture-dislocations of the proximal humerus treated with the proximal humeral internal locking system (philos1) plate in our institution.Between january 2008 to december 2012, a total of 81 patients out of the 97 patients (39 male and 42 female) with a mean age of 56 years (range 20-86 years) with 82 proximal humerus fractures, 1 patient had bilateral fracture were included in the study.Twelve patients also presented with fracture-dislocation.Fractures were classified using the neer classification.There were seven two-part fractures, 40 three-part fractures and 35 four-part fractures.All patients received a similar physical therapy programme following internal fixation.At admittance, one patient had axillary artery vascular injury, which was repaired with an autograft venous transplantation, and incomplete brachial plexus neuropraxia.The mean follow-up was 32 months (range 12-66).The following complications were reported as follows: the mean constant¿murley score for the injured side was 75 points (range 42¿92); moderate results for 17 and poor for five.A (b)(6) year-old female had an impingement syndrome.Additional patient consequences are captured on related complaints (b)(4).This report is for an unknown quantity of unknown philos screws.This is report 6 of 10 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, 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: 8907795
• MDR Text Key: 154912858
• Report Number: 8030965-2019-67469
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 07/23/2019
• 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: 73 YR