MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: ZERO-P; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: zero-p/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.

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: wang, h.E al (2021), is cervical disc replacement valuable in 3-level hybrid surgery compared with 3-level anterior cervical discectomy and fusion?, world neurosurgery, vol.146 (xx), pages e151-e160 (china).The aim of this retrospective study is to compare the clinical and radiologic outcomes of 3-level hs and 3-level acdf and explore the performance of cdr in 3-level hs.A total of 101 patients: 64 patients (31 male and 33 female; mean age=52.75 ± 7.45 years) in the hs group and 37 patients (17 male and 20 female; mean age=65.49 ± 11.01 years) in the acdf group were included in the study.Surgery was performed using zero-p implant (synthes gmbh switzerland, oberdorf, switzerland) in acdf group and together with a competitor device in hs group.Radiologic outcomes were assessed 1 week, 3 months, and 1 year postoperatively and at the final follow-up.The mean follow-up period was unknown.The following complications were reported as follows: the hs group had more blood loss (82.34 ml vs.67.30 ml) compared with the acdf group.In an unknown number of patients, cervical lordosis of c2-c7 was significantly improved immediately after surgery in both groups but gradually decreased during follow-up.In an unknown number of patients, range of motion of c2-c7 was decreased compared with baseline in both groups, but greater range of motion was preserved in the hybrid surgery group compared with the anterior cervical discectomy and fusion group.The fusion rate was 42.71% at 3 months and 84.38% at 1 year postoperatively in the hs group and 48.65% at 3 months and 88.29% at 1 year in the acdf group.However, both groups achieved solid fusion by the final follow-up.In an unknown number of patients, rom of the adjacent superior segment slightly declined in the hs group but significantly increased in the acdf group (8.24° vs.10.53°, p < 0.001) (figure 6).24 patients in the hs group had heterotopic ossification (ho) at the final follow-up.In 3 patients, high-grade ho was observed.9 patients in the hs group and 5 patients in the acdf group reported dysphagia postoperatively.However, symptoms of all patients gradually disappeared within 6 months after surgery.This report is for an unknown synthes zero-p constructs.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11665555
• MDR Text Key: 245398454
• Report Number: 8030965-2021-02896
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention