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

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown zero-p construct/unknown lot.Part and lot number 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

This report is being filed after the review of the following journal article: wang, f.Et al (2021), a case-control study of cervical spine key -hole technique and anterior cervical zero-p system in the treatment of cervical spondylotic radiculopathy, china journal of orthopaedics and traumatology, vol.34 (1), pages 33-39 (china).The aim of this retrospective study is to explore the short-term clinical efficacy of single stage cervical spondylotic radiculopathy (csr) between the minimally invasive key hole technique and anterior cervical zero profile intervertebral fusion system (zero-p).Between january 2017 to january 2020, a total of 45 patients (26 male and 19 female) with an age range of 35 - 78 years were included in the study.Among them, 21 patients (12 male and 9 female) with a mean age of 49.5 ¿ 11.6 years were treated with spinal endoscopy (key-hole group) and followed up for 10 - 22 (13.2 ¿ 2.3) months; and 24 patients (14 male and 10 female) with a mean age of 50.3 ¿ 10.5 years were treated with zero-p intervertebral fusion using zero-p system fusion cage (johnson & johnson, usa; zero-p group) and followed up for 10 - 23 (12.7 ¿ 1.9) months.The following complications were reported: 2 patients developed upper limb hyperalgesia after the operation, and the symptoms were relieved after dehydration and elimination of the nerve root edema.2 patients developed pharyngeal discomfort, which improved after phlegm reduction and atomization treatment.1 patient had dural sac tear during decompression, and there was no postoperative cerebrospinal fluid leakage after suturing of the dura mater and local coverage with biological patch.This report is for an unknown synthes zero-p constructs.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for pc (b)(4).

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS 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: 11694860
• MDR Text Key: 246316152
• Report Number: 8030965-2021-03082
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2021

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: 03/26/2021
• Initial Date FDA Received: 04/20/2021
• 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