MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Tissue Damage (2104); Pressure Sores (2326); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown uss mono/polyaxial screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between implant date is between june 2011 to june 2017.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: zhang r., et al (2019) lumbopelvic fixation versus novel adjustable plate for sacral fractures: a retrospective comparative study,journal of investigative surgery, 0, pages 1-9 (china).This study aims to compare the therapeutic effects of the lumbopelvic technique and a novel adjustable plate for displaced sacral fractures.From 2011 to june 2017, a total of 50 patients including 21 cases treated using the lumbopelvic technique (group a) and 29 cases with a novel adjustable plate (group b) were eligible to this study and were divided into two groups: group a (lumbopelvic fixation) and group b (novel adjustable plate).8 cases did not complete one year of follow-up.Thus, 18 cases in group a (8 males and 10 females) aged 37.56 ± 9.44 years and 24 cases in group b (16 males and 8 females) aged 39.75 ± 8.41 were included in this study.For the patients in group a, the universal spinal system (uss, synthes, synthes, switzerland) was employed to accomplish lumbar polyaxial pedicle screw placement in l4 and l5 vertebra.The components of the novel adjustable plate (tianjin zhengtian medical instrument company ltd., tianjin, china) were used in group b.Follow-up was performed at 1, 2, and 3months postoperatively and every 3months thereafter to evaluate fracture healing and functional recovery.The following complications were reported as follows: in group a, decubital ulcer caused by prominent screw heads developed in a patient.Hematoma developed in two cases, and puncture was performed in a timely manner.One case of infection was noted in each group, and relevant symptoms disappeared after the thorough debridement and antibiotic treatment.This report is for an unknown synthes universal spinal system.This report is for one (1) unknown uss mono/polyaxial screw.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 9990844
• MDR Text Key: 194154602
• Report Number: 8030965-2020-03065
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/23/2020
• 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