MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This is a literature article and patient information is not available for reporting.This report is for an unknown biomaterial - cement: vertecem v+.Part and lot numbers are unknown; udi number is unknown.Dates are unknown as this is an literature article.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: schmitz, p.Et al (2018), clinical application of a minimally invasive cement-augmentable schanz screw rod system to treat pelvic ring fractures, international orthopaedics, pages 1-7, (germany).The objective of this retrospective study is to analyze the first clinical results obtained by the use of the uss fracture mis to treat pelvic ring fractures irrespective of the fracture entity.Between december 2012 and december 2014, 25 patients with pelvic ring fractures were included in the study.These patients were divided into 2 group; group i consisted of 10 patients (6 male and 4 female), with a mean age of age 48.4 ± 19.7 years while group ii consisted of 15 patients (1 male and 14 female), with a mean age of 77.5 ± 10.1 years were treated with unknown synthes universal spine system fracture minimally invasive schanz screw system (uss fracture mis).Follow-up was done in 6 months.The following complications under group i were reported as follows: 1 patient needed cement augmentation due to osteoporotic bone structure.The 2 patients developed sirs.The 2 patients had pneumonia during the time of intensive care.The 1 patient needed revision surgery due to insufficient reduction and simultaneous pedicle screw displacement.The 1 patient had subcutaneous hematoma.Patient underwent conservative treatment.The 1 patient needed a walking aid when using stair case at 6 months follow-up.The following complications under group ii were reported as follows: 14 patients needed cement augmentation due to osteoporotic bone structure.The 1 patient sustained a deep vein thrombosis.The 1 patient had a pulmonary embolism without any sign of a deep vein thrombosis.The 6 patients had neurological deficits and were related to the trauma and not to the operative treatment.The 1 patient had subcutaneous hematoma.The 1 patient had superficial wound infection.Local debridement was performed.The 1 patient had implant failure.Patient underwent revision surgery.The 2 patients had cement leakage into soft tissue.Patient underwent revision surgery.The 3 patients needed a walking aid when using stair case at 6 months follow-up.The 2 patients were just able to be mobilized in a wheelchair due to their geriatric general condition.The 1 patient had a breakage of schanz screw, placed in the ilium occurred close to the connecting clamp.The article did not specify which group the patient belongs.This report is for an unknown synthes universal spine system fracture minimally invasive schanz screw system (uss fracture mis).Cement leakage into soft tissue.This is report 3 of 3 for (b)(4).

• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7908163
• MDR Text Key: 122000125
• Report Number: 8030965-2018-56659
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2018
• 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