MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE

Catalog Number UNK - SCREWS: LOCKING: SPINE

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

Patient Problems Dysphagia/ Odynophagia (1815); Osteolysis (2377); Physical Asymmetry (4573)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: 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.This report is for an unknown - screws: locking /unknown lot.Part and lot number are unknown.Without the specific part number; the 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filed after the review of the following journal article: scholz m, et al (2020), two-level acdf with a zero-profile stand-alone spacer compared to conventional plating: a prospective randomized single-center study, european spine journal, volume 29, page 2814-2822, (germany).This prospective randomized controlled study aimed to compare the clinical and radiological outcome of a zero-profile stand-alone spacer versus a cage plus plate construct in a two-level acdf procedure.In a 3-year timeframe, 41 patients with radiculopathy and/or cervical myelopathy consistent with a contiguous two-level cervical spondylopathy and failure of conservative treatment were included in the study.There were 24 males and 17 females with a mean age of 54 (range, 36-76) years.These patients were randomly assigned to the interventional group and to the control group.The interventional group consisted of 21 patients (13 males and 8 females, mean age 58 (range, 42-71) years) who were all implanted with an unknown synthes zero-profile cage.The conventional group consisted of 20 patients (11 males and 9 females, mean age 58 (range 43-80) years) who were all implanted with an unknown synthes syncage-c and unknown synthes cervical spine locking plate.All cages were filled with an unknown synthes chronos beta-tricalcium phosphate cylinder.Patients were fully mobilized from the first day after surgery without a cervical collar.An active rehabilitation program was offered 12 weeks after the operation.Follow-ups were done at 3-, 6-, 12- and 24-months postoperatively.Complications were reported as follows: interventional group: 7 patients had mild dysphagia at 3 months follow-up.3 patients had mild dysphagia at final follow-up.Unknown patients had slightly lower fusion rates.Unknown patients had a loss of bisegmental correction (4.8 degrees).Unknown patients had a loss of global correction (3.3 degrees).Unknown patients had development of adjacent segment degeneration (asd) or an increase in already existent asd.Conventional group: 12 patients had mild dysphagia at 3 months follow-up.6 patients had mild dysphagia at final follow-up.Unknown patients had a loss of bisegmental correction (4.3 degrees).Unknown patients had a loss of global correction (3 degrees).Unknown patients had development of adjacent segment degeneration (asd) or an increase in already existent asd.These impacted products capture the following events: mild dysphagia.Loss of bisegmental correction.Loss of global correction.Development of adjacent segment degeneration or an increase in already existent asd this report is for the unknown synthes zero-profile cage chronos, unknown syncage-c chronos, and unknown synthes cervical spine locking plate.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11664749
• MDR Text Key: 245380924
• Report Number: 8030965-2021-02886
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: LOCKING: SPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention