MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Event year reported as 2018; however exact date of cement leakage is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).A review of the device history records has been requested.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 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 the vertecem v+ cement was ended up to patient's superior vena cava after injected to the patient's two vertebras.Initially, the patient underwent a spinal procedure on december 11, 2018.There was a 1.5 cc cement volume per pedicle.Procedure performed following vertecem v+ surgical technique, which is familiar to surgeons and or-staff involved.Injection started 6 minutes after mixing the cement.There was no information about the revision surgery as of this time.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device history lot part: 07.702.016s lot: 8c53231 manufacturing site: (b)(4) supplier: osartis (b)(4) release to warehouse date: 09.Jul.2018 expiry date: 01.Mar.2021 the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations.Device history batch, null device history review review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.

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.Device history lot, part: 07.702.016s, lot: 8c53231, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 09.Jul.2018, expiry date: 01.Mar.2021.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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

It was reported that the vertecem v+ cement was ended up to patient's superior vena cava after injected to the patient's two vertebras, and the patient experience infection, inflammation and delayed healing postoperatively.Initially, the patient underwent a spinal procedure on (b)(6) 2018.There was a 1.5 cc cement volume per pedicle.Procedure performed following vertecem v+ surgical technique, which is familiar to surgeons and or-staff involved.Injection started 6 minutes after mixing the cement.X-ray was taken on an unknown date.On (b)(6) 2018, the patient underwent thoracoscopic surgery/partially open thorax surgery and the cement was removed from patient's superior vena cava.It was unknown if there was a surgical delay.Patient outcome was unknown.

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.A product investigation was conducted.Product was not returned.Only dried pieces of cement were returned.The cement parts were forwarded to the legal manufacturer osartis for evaluation.Here their statement.The batch documentation and the test of the retain samples of the affected batch does not show any deviation.The standard application behavior (in accordance with your customer target value) is specified for handling at 23 °c.We did not get any information about the surgery conditions.We would suggest that your sales team should contact the user to discuss potential problems during usage of the vertecem v+ cement kit.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.Additional narrative: updated event description.Test/laboratory data.Reporter's email address.Additional patient codes.Corrected data: initial reporter occupation 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

It was reported that the vertecem v+ cement was ended up to patient's superior vena cava after injected to the patient's two vertebras, and the patient experience infection, inflammation and delayed healing postoperatively.Initially, the patient underwent a spinal procedure on (b)(6) 2018.There was a 1.5 cc cement volume per pedicle.Procedure performed following vertecem v+ surgical technique, which is familiar to surgeons and or-staff involved.Injection started 6 minutes after mixing the cement.X-ray was taken on an unknown date.On an unknown date, the patient underwent thoracoscopic surgery/partially open thorax surgery and the cement was removed from patient's superior vena cava.It was unknown if there was a surgical delay.Patient outcome was unknown.

• Brand Name: SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8264759
• MDR Text Key: 133706022
• Report Number: 8030965-2019-60123
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• 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,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 8C53231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 06/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention