MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL LOR 11X12X27 5 DG; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	187827512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code mqp;odp.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during the surgery of open reduction and intervertebral fusion with pedicle screw fixation for lumbar spondylolysis, when insert the device, the device was cracking.Another device was used to complete the surgery.There was no surgical delay.It was unknown if the surgery completed successfully.There were no adverse consequences to the patient.Concomitant device reported: unknown inserter (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) concorde bul lor 11x12x27 5 dg.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.H10 additional narrative: h3, h6: part: 187827512; lot: 518412x40; no non-conformances were observed during the manufacturing process.The product was released on: january 21, 2020.Visual inspection: the concorde bul lor 11x12x27 5 deg was returned and received at us customer quality (cq).Upon visual inspection, the device was observed to be broken into three fragments and the broken fragments were returned.There were scratches and the etching on the device started to fade but have no impact on the device functionality.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection was performed on the returned fragments of the device.The thickness was measured to be within the specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed concorde bullet size 11x27, hgts 12-13, 5 deg.Investigation conclusion: the complaint condition is confirmed for the concorde bul lor 11x12x27 5 deg.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 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: CONCORDE BUL LOR 11X12X27 5 DG
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10569998
• Report Number: 1526439-2020-01773
• Device Sequence Number: 3167774
• Product Code: MAX
• UDI-Device Identifier: 10705034140193
• UDI-Public: 10705034140193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 187827512
• Device Catalogue Number: 187827512
• Device Lot Number: 518412X40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS