MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: SPINE; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown chronos strip/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: hrabálek l., wanek t., and adamus m.(2010), xlif ¿ a new technique of the lumbar vertebra replacement: initial experience, rozhledy v chirurgii, vol.89 (12), pages 784-788 (czech republic).The aim of this study is a description of the surgical procedure of xlif, its difficulties and advantages, based on our experiences with first patients.Between november 2009 to february 2010, a total of 11 patients with age ranging from 28 to 67 years were included in the study.Surgery was performed using oracle implants (synthes, usa) and strips from beta-tricalcium phosphate (chronos strip, synthes, usa).The mean follow-up period was unknown.The following complications were reported: in the first operated patient, an l5 nerve root traction occurred on the left during l4/5 surgery as a result of excessive expansion of the space where the implant was inserted by the expansion device.This resulted in a temporary and partial paresis and dermatomal hyperesthesia of l5 on the left, the patient reported no pain.2 patients complained of transient painful flexion in the left hip as a result of a trans-psoatic approach, one patient immediately after surgery and the other after 1 week.This report is for an unknown synthes oracle cage and unknown synthes chronos strip.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: SPINE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 12341818
• MDR Text Key: 267247964
• Report Number: 8030965-2021-06826
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 07/21/2021

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: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• 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