MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH STANDARD PARALLEL TRIAL 6MM; SPINAL TRIAL IMPLANT

Model Number	273350106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device received.A review of the device history record.Device history lot: vg2 cervical trial stand 4x6.A review of the receiving inspection (ri) for vg2 cervical trial stand 4x6 was conducted identifying that lot number bw0804 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 19 sep 2004 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer device history batch null, device history review.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Investigation summary updated event description: libertas: it was reported that on november 18, 2019, the vg2 cervical trial stand 4x6 was found to be broken during reverse logistics audit of returned device at (b)(6).There was no patient involvement and no additional information is available.Flow: damage.Visual inspection: visual inspection performed at customer quality (cq) identified the instrument broke along the radel handle.The break is jagged and oblique.No new issues were identified.A device failure was identified.Dimensional inspection: document specification.The following documents were reviewed as part of this investigation: vg2 cervical wedged trial spacer assembly: (b)(4).Machined w/ silk screen, med-small radel handle (use w/ strike plate): (b)(4).Molded blank w/ silk scrn med-small radel handle (use w/ strike plate): (b)(4).Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.
Event or Problem Description
Libertas: it was reported that on november 13, 2019, the exp 635/635 cls/cls sdxsd con was found to be broken during reverse logistics audit of returned device at (b)(6).There was no patient involvement and no additional information is available.This complaint involves one (1) vg2 cervical trial stand 4x6.This report is 1 of 1 for (b)(4).

• Brand Name: STANDARD PARALLEL TRIAL 6MM
• Common Device Name: SPINAL TRIAL IMPLANT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9702099
• Report Number: 1526439-2020-00529
• Device Sequence Number: 2423197
• Product Code: HWT
• UDI-Device Identifier: 10705034189154
• UDI-Public: (01)10705034189154
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 273350106
• Device Catalogue Number: 273350106
• Device Lot Number: BW0804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1