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

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

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Necrosis (1971); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - plates: trauma/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.Investigation summary: product was not returned.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

Device report from taiwan reports an event as follows: this report is being filed after the review of the following journal article: fang-yao chiu, chuan-mu chen, and wai-hee lo (2000), surgical treatment of displaced acetabular fractures ð 72 cases followed for 10 (6±14) years, international injury of the care of the injured vol.31(3), pages 181-185 (taiwan).This retrospective study was made to evaluate the results in treating displaced acetabular fractures surgically without 3d ct, neural monitoring and prophylactic strategies for heterotopic ossification or thromboembolism.Between may 1984 and 1992, a total of 72 patients (51 males and 21 females) with a mean age of 51 years (range, 19-82 years) were included in the study.These patients had displaced acetabular fractures and were managed with open reduction and internal fixation with the use of ao reconstruction plates and screws.The mean duration of follow-up was 10 years.The following complications were reported as follows: 2 with a persistent incomplete peroneal nerve palsy, but these 2 were both evaluated as having good functional results.1 case of iatrogenic sciatic nerve injury (incomplete peroneal component involvement) which was managed non-operatively and recovered with a residual sensory deficit.1 case of femoral artery perforation which was repaired.1 case of deep vein thrombosis which was managed with anti thromboembolic agents and subsided smoothly.2 cases of superficial wound infections which healed after repeated debridement and antibiotics.20 cases with heterotopic ossification which were all managed non-operatively with no medication or irradiation.4 cases with avascular necrosis of the femoral head which were all managed with total hip replacement and were all rated as poor functional results.1 was in a non-congruent reduction.10 cases with symptomatic arthritis which were managed nonoperatively in 4 (fair functional results) and with total hip replacement in 6 (poor functional results).8 were in non-congruent reduction and 2 had initial dislocation with early reduction.2 cases with no initial dislocation and with congruent reduction still got congruent symptomatic arthritis.And both were in fair functional grade.5 had a poor or fair functional results and only 1 fair result (brooker grade iii) of the 5 got congruent reduction.1 heterotopic ossification (grade i) occurred in the 19 cases with ilioinguinal approach.15 heterotopic ossification (grade i in 8, grade ii in 6 and grade iii in 1) occurred in the 47 cases with kocher-langenbeck approach 4 heterotopic ossification (grade ii in 2 and grade iii in 2) occurred in the 6 cases with extended iliofemoral approach.17 of the 20 cases with heterotopic ossification were in mild grade (i/ii).This report is for an ao reconstruction plates and screws.This report is for one (1) unk - screws: trauma.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8890260
• MDR Text Key: 154703574
• Report Number: 8030965-2019-67185
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention