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

Catalog Number	283910000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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 confidence cement was used to fill l3.The mixing and assembly process went smoothly during the operation.After pouring 2ml of bone cement, the doctor felt the pressure decreasing and discovered that the milk bottle was leaking again.After reassembly, it was still leaking.The bone cement could no longer be pressurized.After urgently contacting the supervisor, the doctor was allowed to open another bag for use.There were no patient consequences.
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.
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: g1 (manufacturing site name).H3, h6: photo investigation: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed the cement kit pump and cement reservoir were observed assembled.Cement was observed inside the reservoir.Functionality of the device cannot be assessed through photo evidence provided; there is not enough evidence to confirm the reported condition.Cement lot number 4597805 is identified to be used with the confidence kit: lot number 424363.Retain test was performed for the cement lot number: 4597805, refer to attachments for more details "(b)(4) report - signed".There are no non-conformances associated with this lot.The samples were tested in a temperature and humidity-controlled laboratory.Lot: 4597805, dough time: 34s (spec: max 90s), mix characteristics: stiff, setting time: 14 mins 55s (spec: 12 min 00s - 24 min 00s).The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref: ms-040 confidence spinal bone cement master specification).Setting time was tested using tm-t150 (comparative test for tmt077).The recorded setting met the control specification of 12 min 00 sec - 24 min 00 sec for tm-t077.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.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 j&j medtech orthopaedics 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: 424363, it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 10-feb-2025, manufacturing site: jabil le locle, expiry date: 31 jan 2027.Cement : product code: 183901001/ lot number: 4597805.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.H11 additional narrative: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the pump and the cement reservoir were attached, hardened cement was observed inside the reservoir and a small quantity of liquid was found along the connector tube.The introducer needles and the mixer were also returned with evidence of hardened cement.The mallet and needle holder were returned inside its sealed blister.A complete functional test can not be performed due to the complaint condition can not be replicated; however, the pump was intended to spin and the remaining liquid moved along the tube with no leakage observed.Cement lot number 4597805 is identified to be used with the confidence kit: lot number 424363.Retain test was performed for the cement lot number: 4597805, (b)(4).There are no non-conformances associated with this lot.The samples were tested in a temperature and humidity-controlled laboratory.Lot: 4597805, dough time: 34s (spec: max 90s), mix characteristics: stiff, setting time: 14 mins 55s (spec: 12 min 00s - 24 min 00s).The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref: ms-040 confidence spinal bone cement master specification).Setting time was tested using tm-t150 (comparative test for tmt077).The recorded setting met the control specification of 12 min 00 sec - 24 min 00 sec for tm-t077.Surgical technique of confidence spinal cement system was reviewed and the following relevant notes were found at page 10: connect the hydraulic pump flexible tube to the cement reservoir cap by pushing and snapping the quick connect assembly onto the cement reservoir cap.If the quick connect will not attach to the reservoir cap, rotate the handle of the hydraulic pump counterclockwise to relieve some pressure.This will allow the connector to attach to the reservoir cap.A dimensional inspection 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 j&j medtech orthopaedics 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: a dhr evaluation was performed for the finished device.Product code: 283910000.Lot number: 424363.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 10-feb-2025.Manufacturing site: jabil le locle.Expiry date: 31 jan 2027.Cement: product code: 183901001/ lot number: 4597805.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 ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22976099
• Report Number: 1526439-2025-01124
• Device Sequence Number: 9177202
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623(17)270131(10)424363
• 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: 424363
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/11/2025; 11/13/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/12/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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