MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: uss ii/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Investigation summary 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.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 synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: futamura k et al (2018), ¿within ring¿-based sacroiliac rod fixation may overcome the weakness of spinopelvic fixation for unstable pelvic ring injuries: technical notes and clinical outcomes.International orthopaedics.Volume 42.Pages 1405-1411.(japan).The objective of this study was to explain the surgical procedure of ¿within ring¿-based sacroiliac rod fixation (sirf) and present clinical outcomes.Between january 2012 and december 2016, 15 patients with pelvic ring fracture treated with sacroiliac rod fixation were included in the study.There were 10 male and 5 females with a mean age of 49.5 years old (range, 20-83 years old).Patients were implanted with an unknown synthes universal spine system ii (uss ii) ilio-sacral, modular system with universal spine system ii dual-core cancellous polyaxial screws.The mean follow-up period was 23.8 months (4¿50 months), and bone union was achieved in all patients.3 patients were loss to follow-up.Complications were reported as follows: an (b)(6) year-old male patient died during hospitalization.A (b)(6) year-old male patient had a deep infection and was treated with lavage and debridement.In fig.2 (d), 1 patient had a right s1 pedicle screw that was directed too medially that the screw deviated into the spinal canal.The patient complained of numbness of the s1 region after surgery.Implant removal was scheduled soon after bone union.The article mentioned 3 patients who had implant removal within 1 year after surgery; 2 due to implant irritation and 1 by patient request.Table 1 identified the following 3 patients who had implant removal, however, the reason for each implant removal was not specified: a (b)(6) year-old male patient had implant removal.A (b)(6) year-old male patient had implant removal.A (b)(6) year-old female patient had implant removal.This report is for one (1) device- an unknown synthes universal spine system ii.This is report 5 of 5 for (b)(4).

• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8501617
• MDR Text Key: 141577353
• Report Number: 8030965-2019-62685
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: 03/18/2019
• 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