MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 08.815.111S

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that information received from sales rep as follows: the patient is female, (b)(6) no previous surgeries of the spine.The patient was operated the first time at monday the (b)(6).During this operation, when they had to place the aiming device at the implant (the implant was placed in the patient with the squid) and should use the awl/place the screws, the titanium plate separated from the peek part.They then removed the implant and tried again with a second implant and the same happened.This second implant was then assembled and then they were able to only place two screws.Then the patient was closed.The patient had to be re-operated on thursday the (b)(6).The implant was moving out of the disc-space/the screws were not placed in the right position/potentially could damage the big vessels.This operation went well, a new cage was placed without problems ¿ everything were tested outside the patient before placing the cage in the patient.The staff say, they have used the right size aiming device.This (b)(4) captures the separation of the synfix evolution spacer small intraoperatively while this (b)(4) captures the synfix evolution spacer small was moving out of the disc-space and the misplaced synfix evolution locking screws post-operatively.Implants involved: 08.815.111s lot l713065 synfix evo.Cage, 08.815.111s lot 9846405 synfix evo.Cage, 04.835.125.02s - no lots.This report is for one (1) synfix® evolution spacer.This report is 2 of 3 for (b)(4).

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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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: h3, h6 investigation summary: device history lot: part number: 08.815.111s; lot number: 9846405; manufacturing site: hägendorf; release to warehouse date: 20.May 2016; expiry date: 01.May 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The complained part was forwarded to the product development center for evaluation.Here the investigation result.The returned devices are shown moderate normal wear and tear from usage.The returned implants (cage and screws) are worked as intended during investigation.An intact of cages and screw with the sawbones could be achieved without any malfunction or observation.Note: the functional test is conducted only through returned cages 08.815.111s - l713064, 08.815.111s ¿ 9846405 and screws 04.835.125.02s (3l24148).Per stg, the cage should be screwed with the patient body, by use of 4 screws.As we received only 2 screws as part of this complaint, the functional test is conducted and completed by use of 2 other screw from demo set.According to synthes synfix evolution surgical technique guide, the functional test has been conducted by inserting the returned implant 08.815.111s (l713064), into the saw bone by use of intended instrument squid and the screws 04.835.125.02s (3l24148) has been inserted through correct size aiming device and tightened by use of appropriate screwdriver.During, this whole functional test, there is no malfunction with the implant and screws are identified.This same procedure has been repeated with the other implant 08.815.111s (9846405) and same screws 04.835.125.02s (3l24148) from complaint, and there is no malfunction with the implant and screws are identified.In complaint description it is mentioned that surgeon can place only 2 screws, but no further information is provided, hence it is unable to find out the reason why surgeon is not able to insert 2 more screws to the construct during surgery.Also, we did not receive the aiming device which was used during surgery as part of this complaint, so we are unable to find out the exact reason regarding to the registered complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.H11 corrected data: b5 updated event description.D11 additional concomitant device listed & therapy dates updated.G1 manufacturer contact details updated.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 denmark as follows: it was reported that the patient, a 26-year-old female, with no previous surgeries of the spine had to be re-operated on (b)(6) 2019.The first time the patient was operated on was (b)(6) 2019.During this operation, surgeons place the aiming device at the implant (the implant was placed in the patient with the squid) and should have used the awl in place of the screws.The titanium plate was separated from the peek part.Surgeon removed the implant and tried again with a second implant and the same thing happened.This second implant was then assembled, and only two screws were able to be placed.At this point, the patient was closed.The patient had to be re-operated on (b)(6) 2019.During surgery, the implant was moving out of the disc-space and the screws were not placed in the right position and had potential to damage the big vessels.However, the operation went well, a new cage was placed without any problems.It was reported that everything was tested outside the patient before placing the cage in the patient.Per the staff, right size aiming device was used.Surgery was delayed by at least 30 minutes.Concomitant device reported: unknown synfix evolution aiming device (part# unknown, lot# unknown, quantity# 1).Unknown - awls/taps: spine (part# unknown, lot# unknown, quantity# 1).This (b)(4) captures the separation of the synfix evolution spacer small intraoperatively while the (b)(4) captures the synfix evolution spacer small that was moving out of the disc-space, and the post-operatively misplaced synfix evolution locking screws.The complaint involves three (3) devices implants involved: 1.08.815.111s lot l713065 synfix evo.Cage ¿ qty 1.2.08.815.111s lot 9846405 synfix evo.Cage ¿ qty 1.3.04.835.125.02s - no lot number provided ¿ qty 2.This report is for one (1) synfix® evolution spacer.This report is 2 of 3 for (b)(4).

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.H6: patient code change to injury.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.

• Brand Name: SYNFIX EVOLUTION SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9137416
• MDR Text Key: 160850289
• Report Number: 8030965-2019-68871
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07612334081933
• UDI-Public: (01)07612334081933
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.815.111S
• Device Lot Number: 9846405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1
• Treatment: UNK - AWLS/TAPS.; UNK - AWLS/TAPS.; UNK SYNFIX EVOLUTION AIMING DEVICE.
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR