MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT PLIF CAGE, H:16MM, 26/9, 18°

Model Number PEI91606

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluated by mfr: 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

Revision operation due to a symptomatic pseudoarthrosis of l1/2 (level of interbody) > 12 months post-operatively in the first surgery, a plif cage, h:16mm, 26/9, 18°, with the reference number pei91606, which is a plif cage without a bone graft hole and which is not cleared by the fda, was implanted into a patient in a hospital in australia.The surgeon was of the opinion that screw loosening and the fracture of one the two loose screws at the top of the construct was due to pseudoarthrosis of the proximal level where a single 18 degree 16mm high eit plif cage was placed obliquely across the disc space via an mis tlif approach.Fusion of l2-4 was demonstrated following a previous fusion predating this one.The surgeon revised all screws l1-4 on (b)(6) 2018 and placed a k2m cascadia tlif oblique cage next to the eit cage leaving this insitu.Infuse was used in the cage and disc space.

• Brand Name: EIT PLIF CAGE, H:16MM, 26/9, 18°
• Type of Device: PLIF CAGE
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer Contact: barbara wirth ; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 8447466
• MDR Text Key: 139695125
• Report Number: 3013730328-2019-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PEI91606
• Device Catalogue Number: N/A
• Device Lot Number: E17LA0039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2018
• Device Age: 15 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "STREAMLINE" BY RTI SURGICAL ON L1 TO L4
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR