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

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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: sommer, c.Et al (2003), first clinical results of the locking compression plate (lcp), injury, international journal of the care of the injured, vol.34, pages s-b43-s-b54 (switzerland).The aim of the present study was to investigate the results of an initial application of the lcp by experienced traumatologists across a wide range of indications and to draw conclusions relevant to routine clinical application.Between march 2000 to february 2001, a total of 144 patients (67 female and 77 male) with mean age of 51.4 years (range 11 - 93 years) were included in the study.Patients over 70 years of age (n=35), 28 were women and 7 were men.These patients had a total of 169 fractures: of these, 57 were tibial fractures, 45 humerus, 19 radius and 18 femoral.In 130 fractures (86%), healing took place within the expected period and without complication or secondary dislocation (¿uneventful healing¿).The mean duration of follow-up was 12 months.The following complications were reported as follows: (b)(6) year-old male had an implant loosening caused by technical errors.(b)(6) year-old female had an early implant failure in a transverse periprosthetic femoral fracture.1 patient had loosening of the implant.1 patient had loss of reduction.4 patients had breakage of the implant.2 patients had infection.2 patients had postoperative nerve palsy.2 patients had osteonecrosis.4 patients had refracture (ii fracture close to the implant) 5 patients had delayed or non-union.4 patients had plate failure.5 patients had secondary fractures immediately adjacent to the implant after a subsequent injury.4 patients had loosening of the implant and loss of reduction.2 patients had implant-related pain.18 revision operations were necessary in 13 patients in which 2 revision operations were required to deal with infection and a re-fracture.5 patients died before the fracture had healed without there being any recognizable link between death and the implant; 3 patients died of an existing, malignant tumor; 1 patient died as a result of cardiogenic shock; and 1 patient died of sleep apnea syndrome.This report is for a unknown screw.This is report 10 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8851959
• MDR Text Key: 153064023
• Report Number: 8030965-2019-66717
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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
• Date Manufacturer Received: 07/05/2019
• 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: 46 YR