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Model Number TPL0038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Unspecified Tissue Injury (4559)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
Please note that this date is based off the date of publication of the article as the actual event date was not provided. The reported event was from the following literature article: zhang j, fan y, he x, liu t, hao d. Comparison of robot-assisted and freehand pedicle screw placement for lumbar revision surgery. International orthopaedics 2020. Https://doi. Org/10. 1007/s00264-020-04825-1. If information is provided in the future, a supplemental report will be issued.
Event Description
Abstract: the accuracy of robot-assisted pedicle screw implantation is a safe and effective method in lumbar surgery, but it still remains controversial in lumbar revision surgery. This study evaluated the clinical safety and accuracy of robot-assisted versus freehand pedicle screw implantation in lumbar revision surgery. This was a retrospective study. From january 2018 to december 2019, 81 patients underwent posterior lumbar revision surgery in our hospital. Among them, 39 patients underwent revision surgery performed with robot-assisted pedicle screw implantation (renaissance robotic system), whereas the remaining 42 patients underwent traditional freehand pedicle screw implantation. All patients underwent magnetic resonance imaging (mri), computed tomography (ct), and x-ray before revision surgery. The sex, age, body mass index, bone mineral density, operative time, blood loss, operative segments, intra-operative fluoroscopy time, and complications were compared between the two groups. The accuracy of pedicle screw implantation was measured on ct scans based on gertzbein robbins grading, and the invasion of superior level facet joint was evaluated by babu¿s method. There was no statistical difference about the baseline between the two groups (p > 0. 05). Although there were no significant differences in operative time and complications between the two groups (p > 0. 05), the robot-assisted group had significantly less intra- operative blood loss and shorter intra-operative fluoroscopy times than the freehand group (p <(><<)> 0. 05). In the robot-assisted group, a total of 267 screws were inserted, which were marked as grade a in 250, grade b in 13, grade c in four, and no grade d or e in any screw. In terms of invasion of superior level facet joint, a total of 78 screws were inserted in the robot-assisted group, which were marked as grade 0 in 73, grade 1 in four, grade 2 in one, and grade 3 in zero. By comparison, 288 screws were placed in total in the freehand group, which were rated as grade a in 251, grade b in 28, grade c in eight, grade d in one, and no grade e in any screw. A total of 82 superior level facet joint screws were inserted in freehand group, which were marked as grade 0 in 62, grade one in 18, grade 2 in two, and grade 3 in zero. The robot-assisted technique was statistically superior to the freehand method in the accuracy of screw placement (p <(><<)> 0. 05). Compared with freehand screw implantation, in lumbar revision surgery, the renaissance robot had higher accuracy and safety of pedicle screw implantation, fewer superior level facet joint violations, and less intra-operative blood loss and intraoperative fluoroscopy time. Reported events: 1. Five patients undergoing a spinal procedure using the guidance system experienced dural tears. The dural tears were repaired and there were no wound non-healing infections caused by the dural tear.
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Manufacturer (Section D)
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer (Section G)
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key11041226
MDR Text Key222644840
Report Number3005075696-2020-00146
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1