MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH POST IBF HI H 9MM 8DEG 26/9; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number PHI80906

Device Problems Device-Device Incompatibility (2919); Migration (4003)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 is not distributed in the united states, but is similar to device marketed in the usa.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the customer reported a dislodged conduit plif cage.No patient consequence reported.No further information available.This report is for one (1) post ibf hi h 9mm 8deg 26/9.This is report 1 of 1 for pc-(b)(4).

Event Description

It was reported that the initial surgery was performed on (b)(6) 2021.The reported issue of dislodged conduit plif cage occurred postoperatively.The patient underwent the revision procedure on (b)(6) 2021.The revision procedure was successfully completed by re-placing of the cage.Patient outcome is reported as good.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4; d6a; d6b h3, h4, h6: a device history record (dhr) review was conducted: part # tft30101 lot # e21di0031 supplier: eit batch1: lot qty of 93 units were released on 22 june 2020 with no discrepancies.Batch2: lot qty of 93 units were released on 20 aug 2021 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.G1.

• Brand Name: POST IBF HI H 9MM 8DEG 26/9
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 13168263
• MDR Text Key: 285055864
• Report Number: 3013730328-2022-00006
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 04260557823903
• UDI-Public: (01)04260557823903
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PHI80906
• Device Lot Number: E20CL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 02/11/2022; 03/01/2022; 03/10/2022; 07/15/2022
• Supplement Dates FDA Received: 02/11/2022; 03/09/2022; 04/07/2022; 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CAGE/SPACER: CONDUIT
• Patient Outcome(s): Required Intervention