MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: PEEK; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Hematoma (1884); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown peek cage/spacer/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: kyu choi m., min kim s., jean jo d., (2020) anterior lumbar interbody fusions combined with posterior column osteotomy in patients who had sagittal imbalance associated with degenerative lumbar flat-back deformity: a retrospective case series, neurosurgical review volume 43, pages 1117¿1125 (korea , south).This study aims to describe the surgical experience using multilevel alifs combined with pcos for primary degenerative lfd.A total of 70 consecutive patients (men 9 and women 61) with mean age (years) 66.1 (range, 61¿74) with primary degenerative lfd who underwent corrective surgery were included in the study.A lordotic polyetheretherketone cage (10°, depuy synthes inc.), which was filled with cancellous autograft and allograf was used during surgery.Mean follow-up period (months) 30.2 (range, 24¿80).The following complications were reported as follows: early postoperative complications: 7 cases needed revision surgery (epidural hematoma (n = 1).L3 nerve root compression (n = 1).Four cases of proximal junctional failure (pjf).One of pjf each occurred in pill = 10° and pi-ll -9° to 9° group, two occurred in pi-ll = 10° group.Loss of correction.This report is for an unknown synthes lordotic polyetheretherketone cage.This report is for one (1) unknown peek cage/spacers.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: PEEK
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 11798157
• MDR Text Key: 249726829
• Report Number: 8030965-2021-03735
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 04/14/2021
• 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