MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.647.127S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height reported as 170.0 cm.(b)(6).A review of the device history records has been requested.The device was received, the investigation is in progess, 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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a procedure to implant the zero profile variable angle (zero-p va) implant on (b)(6) 2018, the metallic portion (interbody plate) detached from the polymer portion.Another implant was available and was used to complete the procedure normally with a delay of approximately 5 minutes.All fragments were retrieved.This report is for one (1) zero-p va implant.This is report 1 of 1 for (b)(4).
Additional 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 history records review was completed for part: 04.647.127s, lot: l984078.Manufacturing location: mezzovico, release to warehouse date: jul 23, 2018, expiry date: jul 01, 2028.The device history record shows this lot of (b)(4) pieces 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 records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The device was found in a good condition.The plastic part is detached from the metallic part.The returned device was tested at customer quality department and the complaint condition could not be confirmed.The functionality of the device was given, as the parts could be assembled/ disassembled as per design intended.Investigation has shown that the complaint condition is unconfirmed.The exact root cause could not be determined as no detailed clinical information available.Additionally, the complained malfunction could not be reproduced as device passed the required functional check successfully.Based on this result we conclude that the cause of failure is not due to any manufacturing non-conformances.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.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.
Additional 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.Manufacture date dhr review was completed.Part: 04.647.127s lot: l984078 manufacturing site: mezzovico release to warehouse date: 23.July 2018 expiry date: 01.July 2028 the device history record shows this lot of 8 pieces 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 h3, h6: customer quality conducted an investigation of the returned device investigation selection investigation site: cq zuchwil selected flow: 2.Device interaction/ functional visual inspection: the device was found in a good condition.The plastic part is detached from the metallic part.Function test: the returned depth gauge was tested at customer quality department and the complaint condition could not be confirmed.The functionality of the device was given, as the parts could be assembled/ disassembled as per design intended.Dimensional inspection: not required per selected investigation flow as root cause cannot be reeplicated.Document/ specification review: not required per selected investigation flow as root cause cannot be reeplicated.Summary: our investigation has shown that the complaint condition is unconfirmed.Unfortunately we cannot determine the exact root cause as no detailed clinical information.Also we could not reproduce the complained malfunction as device passed the required functional check successfully.Based on this result we conclude that the cause of failure is not due to any manufacturing non-conformances.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.Udi 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.
Additional 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.Date correction in event description 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 or Problem Description
Device report from synthes europe reports an event in france as follows: it was reported that during a procedure to implant the zero profile variable angle (zero-p va) implant on september 17, 2018, the metallic portion (interbody plate) detached from the polymer portion.Another implant was available and was used to complete the procedure normally with a delay of approximately 5 minutes.All fragments were retrieved.

• Brand Name: ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7958471
• Report Number: 8030965-2018-57240
• Device Sequence Number: 1514642
• Product Code: OVE
• UDI-Device Identifier: 10705034750736
• UDI-Public: (01)10705034750736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.647.127S
• Device Catalogue Number: 04.647.127S
• Device Lot Number: L984078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 11/14/2018; 12/14/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/14/2018; 11/15/2018; 12/14/2018
• Patient Sequence Number: 1
• Patient Weight: 83