MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: SYNFIX; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown synfix construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2012 to (b)(6) 2016.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kapustka, b.Et al (2020), anterior lumbar interbody fusion (alif): biometrical results and own experiences, neurosurgical review, vol.43 (xx), pages 687-693 (poland).The aim of this retrospective study is to measure a degree of indirect foraminal decompression radiologically using a standardised method proposed by rao et al.[20] with correlation to the intervertebral disc parameters and clinical outcome.Between january 2012 to december 2016, a total 51 patients (27 male and 24 female) with a mean age of 41.7 years (± 8.4 years, 24¿59) underwent anterior lumbar interbody fusion surgery.Surgery was performed using peek (polyetheretherketone) interbody spacer including fixation with four locking screws synfix-lr (depuy synthes).All patients were followed up for more than 12 months.Postoperative follow-up for radiologic parameters was a mean of 28 months (12¿59).The following complications were reported as follows: 2 patients complained about transient paresthesia of lower limbs extending throughout the l5 dermatome.1 patient had sympathetic dysfunction, manifesting as left-sided leg warmth and swelling (these symptoms resolved within 6 months).2 patients had superficial wound infection treated with oral antibiotics, with no deep wound infections requiring reoperation or intravenous therapy.This report is for an unknown synthes synfix constructs.This report is for one (1) unknown synfix construct.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SYNFIX
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10119510
• MDR Text Key: 194025951
• Report Number: 8030965-2020-03931
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/28/2020

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: 05/28/2020
• Initial Date FDA Received: 06/04/2020
• 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