MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL LOR 9X10X27, 5 DG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187827410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: mqp.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during the cage insertion process the cage holding part broke.There was a surgical delay of fifteen (15) minutes.Fragments were removed.This report involves one (1) cage.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Date of concomitant therapy is february 28, 2022.H6: given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the photo.Visual analysis of the photo revealed that the concorde bul lor 9x10x27, 5 dg was broken at one end.No other anomalies were noted.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the concorde bul lor 9x10x27, 5 dg.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.
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: investigation summary : the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the concorde bul lor 9x10x27, 5 dg, p/n: 187827410, was broken.No other problems identified.A dimensional inspection was unable to be performed due to post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the concorde bul lor 9x10x27, 5 dg, p/n: 187827410 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 review : a manufacturing record evaluation was performed for the finished device: product code: 187827410, lot number: 325671; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.

• Brand Name: CONCORDE BUL LOR 9X10X27, 5 DG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13930165
• Report Number: 1526439-2022-00471
• Device Sequence Number: 6357265
• Product Code: MAX
• UDI-Device Identifier: 10705034140070
• UDI-Public: (01)10705034140070
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 187827410
• Device Catalogue Number: 187827410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 08/15/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/26/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS
• Patient Sex: Unknown