MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH BENGAL IMPLANT LRG 5MM 7 DEG; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187301205
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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
It was reported that on (b)(6) 2020, during anterior cervical fusion surgery, the surgeon trialed and implanted the bengal cage in the c4-5-disc space.He wanted to revise the position of the implant by pulling the implant back (anteriorly) by a few mms.He attempted to reattach the inserter however the threads on the cage appeared to be stripped and the inserter stylet would not tighten to the cage.He used an up-going curette to remove the implant.We retrieved a new implant and finished the case with successfully.There was a surgical delay of three (3) minutes.There were no patient consequences.The procedure was successfully completed.This complaint involves two (2) devices.This report is 1 of 2 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 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
Concomitant devices reported: insertion instruments (part number unknown, lot unknown, quantity 1).
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.H10 additional narrative: h3, h4, h6 investigation summary visual inspection: the bengal implant lrg 5 mm 7 deg (p/n: 187301205, lot #: 129223) was returned and received at us cq.Upon visual inspection, the threads on the device were observed to be stripped.No other issues were identified with the returned device.Functional test: a functional test was not performed as the returned device was received by itself.Can the complaint be replicated with the returned devices? unable to perform.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed vbr 1, 7 deg, large sizes 4-9 mm.Complaint confirmed? yes, the device received was stripped.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed as the bengal implant lrg 5 mm 7 deg (p/n: 187301205, lot #: 129223) was stripped, which could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history the dhr of product code 187301205, lot 129223, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on april 3, 2017.Qty.40 the dhr was electronically reviewed.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: BENGAL IMPLANT LRG 5MM 7 DEG
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10159283
• Report Number: 1526439-2020-01191
• Device Sequence Number: 14214335
• Product Code: MQP
• UDI-Device Identifier: 10705034137094
• UDI-Public: 10705034137094
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2020

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: 187301205
• Device Catalogue Number: 187301205
• Device Lot Number: 129223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 07/13/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/08/2020; 07/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS