MAUDE Adverse Event Report: SYNTHES GMBH UNK - REDUCTION/RETRACTION/DISTRACTION INSTRUMENTS: SPINE; EXTRACTOR

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The event date is unknown.This report is for an unk - reduction/retraction/distraction instruments: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: byvaltsev v.A., kalinin a.A., minimally invasive dorsal decompression-stabilization surgery in patients with overweight and obesity, voprosy neurochirurgii [neurosurgery topics] volume 82 (5), pages 1-13 (russia) https://doi.Org/10.17116/neiro20188205169.This prospective non-randomized single center study aims to investigate the effectiveness of new, minimally invasive rigid fixation technology and the traditional open method of fusion in the surgical treatment of degenerative diseases of the lumbar segments in overweight and obese patients.From 2010 to 2015 , a total of 73 patients (49 men and 24 women) with a median age of 53 (42¿65) who underwent spinal canal reconstruction, single-level interbody transforaminal fusion with a cage, and transpedicular stabilization for single-level lumbar spine degeneration were included in the study.In group 1 (mis-tlif, n=32) with 21 males and 11 females age, years (me 52 (43; 64) decompression was carried using a minimally invasive quadrant retraction system (medtronic, usa), insight (synthes, switzerland), or aras (zimmer, germany).Transforaminal fusion was then performed with a t-pal (synthes, switzerland) or capstone (medtronic, usa) cage.Next, viper ii (synthes, switzerland) or u-centum (ulrich, germany) transpedicular screws were simultaneously installed ipsilaterally openly or contralaterally percutaneously.In group 2,with 28 males and 17 females age, years (me (25%; 75%) 49.5 (41; 62) discectomy, preparation of the interbody space and transforaminal fusion with a pezo-t (ulrich, germany) or capstone (medtronic, usa) cage were carried out similarly to group 1.Four-screw open transpedicular stabilization with a konmet system (russia) was then performed.Follow-up lasted an average of 34 months in group 1 and 40 months in group 2.The following complications were reported: post-operative complications occurred in 9% in group 1: infections in the surgical intervention region (n=1), adjacent segment disease (n=1), pseudoarthrosis (n=1), muscle atrophy.Group 1 had significantly less severe pain in both the lumbar spine (p<0.05) and the lower limbs (p<0.05) due to less soft tissue injury during the approach.A case of (b)(6) patient from group 1 had muscle atrophy 11%, left 7.14 cm2, atrophy 19.Soft tissue injury during the approach.(intraoperative).This report is for an unknown synthes t-pal cage and unknown synthes insight.This report is for (1) unk - reduction/retraction/distraction instruments: spine this report is 2 of 2 (b)(4).

• Brand Name: UNK - REDUCTION/RETRACTION/DISTRACTION INSTRUMENTS: SPINE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11653510
• MDR Text Key: 261748690
• Report Number: 8030965-2021-02803
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention