MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	283910000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the glass bottle was not filled all the way, it is only 5cc, which is less than the original 11cc.There were no patient consequences.
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.H11 additional narrative: added: d9.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.
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.H11 additional narrative: h6: the product was not returned to depuy synthes; however, a video was provided for review.The video investigation revealed the cement reservoir was observed attached to the hydraulic pump.When handled, cement fell out from the reservoir.Properly handling and attention to the approved use of the device diminishes the risk of failure.A complete potential cause for cement falling out from the reservoir can not be established with available information.Retain test to check the retained ampoules for liquid fill was performed by the vendor.The result of the testing revealed no deviations; hence the a faulty product was excluded.With available information, the reported complaint can not be confirmed; leakage from the ampoule liquid was not identified.The retained ampoules for the above lot were checked and all 10 ampoules inspected contain the correct amount of liquid for the product.All qc and microbiology testing met release specification (ref: ms-040 confidence spinal bone cement master specification).As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the confidence spinal cmt sys, 11c would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a dhr evaluation was performed for the finished device product code: 283910000, lot number: 429998.It was electronically reviewed and no nonconformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: 15-apr-2025.Manufacturing site: jabil le locle.Cement: part number: 183901001, lot number: 4674657.Dhr review retrieved from pi-17598747155963955 as the impacted products share the same lot number.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.H11 additional narrative: added: g1 (manufacturing site name).H3, h4, h6: photo investigation: the product was not returned to depuy synthes; however, a video was provided for review.The video investigation revealed the cement reservoir was observed attached to the hydraulic pump.When handled, cement fell out from the reservoir.Properly handling and attention to the approved use of the device diminishes the risk of failure.A complete potential cause for cement falling out from the reservoir can not be established with available information.Retain test to check the retained ampoules for liquid fill was performed by the vendor.The result of the testing revealed no deviations; hence the a faulty product was excluded.With available information, the reported complaint can not be confirmed; leakage from the ampoule liquid was not identified.The retained ampoules for the above lot were checked and all 10 ampoules inspected contain the correct amount of liquid for the product.All qc and microbiology testing met release specification (ref: ms-040 confidence spinal bone cement master specification).As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the confidence spinal cmt sys, 11c would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Physical device investigation: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the needles and the mallet were returned inside the sealed blister packaging.Cement reservoir was found with hardened cement in the interior.The hydraulic pump was not attached to the reservoir.Ampoule was not returned, only the empty box packaging with ifu.Retain test to check the retained ampoules for liquid fill was performed by the vendor.The result of the testing revealed no deviations; hence the a faulty product was excluded.With available information, the reported complaint can not be confirmed; leakage from the ampoule liquid was not identified.The retained ampoules for the above lot were checked and all 10 ampoules inspected contain the correct amount of liquid for the product.All qc and microbiology testing met release specification (ref: ms-040 confidence spinal bone cement master specification).A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the confidence spinal cmt sys, 11c would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): a dhr evaluation was performed for the finished device.Product code: 283910000.Lot number: 429998.It was electronically reviewed and no nonconformance's/manufacturing irregularities were identified during the manufacturing process.The product was released on: 15-apr-2025.Manufacturing site: jabil le locle.Cement: part number: 183901001, lot number: 4674657.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 2400 ; SZ 2400
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23369856
• Report Number: 1526439-2025-01338
• Device Sequence Number: 21056352
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623(17)270331(10)429998
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Catalogue Number: 283910000
• Device Lot Number: 429998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 12/08/2025; 12/10/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/09/2025; 12/09/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown