MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK - SCREWS: SPINE-US

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

Patient Problems Dysphagia/ Odynophagia (1815); Bone Fracture(s) (1870); Hematoma (1884); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine screws/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.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.Report was initially submitted on september 12, 2019 but the passed third acknowledgement was not received.Advised to resubmit medwatch november 04, 2019.The original submission was made within the 30 day reporting timeline.(b)(4).

Event Description

This report is being filed after the review of the following journal article: koller h., et al (2009), mid- to long-term outcome of instrumented anterior cervical fusion for subaxial injuries, european spine journal, volume 18, pages 630¿653 (austria).This retrospective study aims to investigate a homogenous subgroup of patients with subaxial injuries without sci subjected to acdfp.Between 1996 and 2006,a total of 28 patients treated for cervical spine met the criteria for the study.Out of these , 26 patients (5 female and 21 male) with mean age at injury was 42.4 ± 18.7 years (range 16¿70 years) and 47.7 ± 19.7 years (range 18¿80 years) at follow-up comprised the final sample of the study.Constrained (cs-) plates were used in 3 patients (11.5%, cslp, synthes, paoli, pa, usa).The length of follow-up was 67 ± 37 months on average (median: 60 months, 95%ci: 52¿82 months; range 16¿128 months.The following complications were reported as follows: one patient showed a contiguous superior left-sided facet fracture of t1 with a fracture dislocation of c6¿7.Eight patients (30.8%) had associated facet fractures, 4 (25.4%) had fractures of the lateral mass, and 5 (19.2%) had associated laminar fractures.Patients having a non-union had significantly increased loss of local lordosis (p = 0.005) and a decreased npdi as compared to those who achieved fusion (p = 0.006).1 case where the rsra was 3.1 and the case was classified as non-fused.In patients that had received a cs-plate, the change of the sra was significantly less than if treated with a nc-plate (p = 0.004).A hypomobility was present at c2¿3 level in 2 patients (7.7%), at c3¿4 in 7 (26.9%), at c4¿5 in 3 (11.5%), at c5¿6 in 4 (15.4%), and at c6¿7 in 1 (3.8%).Hypermobility was present in 3 patients at the c2¿3 level (11.5%), and each once (3.8%) at the c3¿4, c4¿5, and c5¿ 6 level.At all, 12 of 23 patients (52.2%) were found to have a deviation greater ±2 sd from normalcy at any of the adjacent-levels.17 patients (65.4%) showed some presence of asd at the first adjacent- cephalad level on follow-up radiograph.A new onset asd was evident in 7 patients on follow-up radiograph.2 patients had no changes of asd (11.7%).On follow-up radiograph.The first adjacent-caudal level was discernable on injury and follow-up radiographs in 22 patients, 14 (63.6%) showed presence of asd.In 4 of 14 patients (28.6%) there was a progression of an already existing degenerative process.New onset asd was evident in 7 patients (50%).3 patients (21.4%) had no change in asd.14 patients (53.8%) were found to have new onset asd at the first adjacent levels merely resembling ossifications of the all.The crom for flexion¿extension was reduced to 79.1% ± 17.5 (range 47¿127.9%) and to 81.8% ± 16.4 (range 16.4¿113.6) for rotation.With increased asd at the first adjacent-cephalad level at follow-up we noticed a significantly reduced clinical rom in flexion¿extension (r = -0.61, p = 0.001).7 patients (53.8%) showed slight to severe reduction of muscle strength in terms of the mrc (2¿4).Radiculopathy did not resolve in 1 patient reporting on intermittent paraesthesias related to the c7 nerve root.2 patients (7.7%) showed postoperative dysphagia that resolved until 3 months follow-up.1 (3.8%) had a postoperative wound haematoma requiring surgical drainage.Further course was uneventful.One patient (3.8%) showed a postoperative right-sided paresis of the hypoglossal nerve that resolved incompletely.Two revision surgeries (7.7%) were performed.Patients noticed higher disability scores for liquids and solids with increasing asd at the first adjacent-cephalad level (r = 0.46, p = 0.02; r = 0.41, p = 0.04).A total of 5 plates (19.2%) impinged on the cephalad and 3 (26.7%) on the caudal disc space (24 assessable adjacent-caudal levels).The incidence of radiographic construct failure was 30.8% (8 patients).The incidence of construct failure was significantly higher in surgeries at the c6¿7 level (p = 0.01) as compared to the more cephalad levels and in patients that postoperatively showed lower correction of the injury kyphosis and translation (p = 0.01; p = 0.02).This is report 2 of 9 for (b)(4).This report is for an unknown synthes spine screws.

• Brand Name: UNK - SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9272005
• MDR Text Key: 185192170
• Report Number: 8030965-2019-68187
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: SPINE-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2019
• 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