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 Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown peek cage/spacers/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2006 to (b)(6) 2009.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.(b)(4).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: zhu, h.F.Et al.(2018), prospective study of long-term effect between multifidus muscle bundle and conventional open approach in one-level posterior lumbar interbody fusion, orthopaedic surgery, vol.10, number 4, pages 296-305 (china).The objective of this study is to compare postoperative imaging results, clinical outcomes and complications between the multifidus muscle bundle (mmb) approach and the conventional open (co) approach in one-level posterior lumbar interbody fusion (plif).From march 2006 to july 2009, a total of 101 patients with lumbar spine disorders underwent mmb-plif or co-plif.A total of 52 patients (25 males and 27 females) were assigned to the mmb-plif group and 49 patients (26 males and 23 females) to the co-plif group.The implants used were polyetherether ketone (peek) interbody cages (synthes, switzerland).In the mmb-plif group, the mean follow-up time was 93.8 months, while for the co-plif group, it was 94.7 months.The following complications were reported as follows: multifidus atrophy rates were much lower in the mmb-plif group at the final follow-up at the final follow-up, there were significant differences in the incidence of adjacent segment degeneration (asd) (3.8% vs 14.3%, reducing by 73.4%, p < 0.05), intractable back pain (3.8% vs 22.4%, reducing by 83.0%, p < 0.05), and residual neurological symptoms (5.8% vs 20.4%, reducing by 71.6%, p < 0.05) between the two groups.This report is for an unknown synthes polyetherether ketone (peek) interbody cage.This report is for one (1) 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: 11798572
• MDR Text Key: 264610247
• Report Number: 8030965-2021-03737
• Device Sequence Number: 1
• Product Code: MQP
• 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: 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