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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for unknown screws: cancellous/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date is between (b)(6) 1978 to (b)(6) 1982.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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: cobb, a.G.And gibson, p.H.(1986), screw fixation of subcapital fractures of the femur - a better method of treatment?, injury, vol.17 (issue 4), pages 259-264 (united kingdom).The aim of this study is to evaluate the efficacy of treatment using a screw fixation for subcapital fractures of the femur.Between january 1978 to december 1982, a total of 71 patients (17 male and 54 female) with age ranging from 30 to 95 years underwent internal fixation.Surgery was performed using three 6.5-mm ao cancellous screws with washers in the fixation.Outpatient follow-up continued at 2-monthly intervals until union of the fracture, and thereafter annually for at least 2 years.65 patients who survived were followed up for 26-73 months from injury (mean 47 months).The following complications were reported as follows: a (b)(6) year old female patient died at 12 months postoperatively.An (b)(6) year old female patient died at 8 months postoperatively.A (b)(6) year old female patient died at 9 months postoperatively.An (b)(6) year old male patient died at 10 months postoperatively.An (b)(6) year old female patient died at 7 months postoperatively.A male psychiatric patient had a nonunion due to failed fixation caused by uncontrolled early and vigorous weight bearing.A (b)(6) year old male patient had avascular necrosis and nonunion and underwent total hip replacement at 8 months after fracture with satisfactory results.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient had avascular necrosis and nonunion and underwent total hip replacement at 24 months after fracture with satisfactory results.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient manifests a failure to achieve union when she began weight-bearing after a poor reduction and poor fixation of a stage iv fracture.A male patient had a postoperative wound infection.He developed inflammation around the wound and fever within the first week.1 patient had a fracture of the subtrochanteric region of the femoral shaft at the point of entry of the ao screws due to fall, and after internal fixation with a jewett nail plate both fractures went on to unite satisfactorily.In 19 out of 52 patients who achieved union without necrosis or displacement of the femoral head, resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.1 patient had stress fracture of one of the screws.4 patients required removal of the screws after sound union of their fractures to relieve local discomfort related to protruding screw heads.A (b)(6) year old female patient had total head necrosis and underwent thr at 28 months after fracture.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient had total head necrosis.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient had total head necrosis and underwent thr at 24 months after fracture.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old male patient had total head necrosis and did not undergo thr.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old male patient had total head necrosis and underwent thr at 24 months after fracture.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient had total head necrosis and underwent thr at 3 months after fracture.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old male patient had total head necrosis.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old female patient had segmental head necrosis.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.An (b)(6) year old female patient had segmental head necrosis.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.A (b)(6) year old male patient had segmental head necrosis and underwent thr at 60 months after fracture.Resorption of bone was sufficient to allow backing out of the screws by up to 1.0cm.This report is for an unknown synthes cancellous screws.This report is for one (1) unk - screws: cancellous.This is report 7 of 10 for (b)(4).This report is linked to (b)(4).

• Brand Name: UNK - SCREWS: CANCELLOUS
• 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: 9297868
• MDR Text Key: 185191375
• Report Number: 8030965-2019-70133
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 10/22/2019
• 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: 58 YR