MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH T-PAL PROTI, 12X16X32 MM; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	108812216
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Common device name and product code not available.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 as no product was received.The investigation could not be completed; 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 synthes reports an event in (b)(6) as follows: it was reported that a mismatch in product labelling between surgical technique guide and the label on the product for proti t-pal and protiacis.This complaint involves one (1) device.This report is 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: investigation summary.Investigation flow: labeling and packaging.Visual inspection: the complaint was evaluated and investigated.The product was not return; therefore, could not be evaluated.Document/ specification review: a device history record review could not be performed, because the lot number was not provided.There was no trend associated with labeling at the time of the investigation.We were unable to validate this complaint due to insufficient information.Complaints of this nature are monitored through tracking and trending and if a trend is detected, further action will be taken through our capa/continuous improvement process.Dimensional inspection: a dimensional inspection could not be performed since the product was not returned.Complaint confirmed? no.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: T-PAL PROTI, 12X16X32 MM
• 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: 9936190
• Report Number: 1526439-2020-00825
• Device Sequence Number: 18993545
• Product Code: MAX
• UDI-Device Identifier: 00819917021820
• UDI-Public: (01)00819917021820
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 108812216
• Device Catalogue Number: 108812216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1