MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SFX CROSS CONNECTOR SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	189401105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp; kwq; mnh; mni; osh.Reporter is a j&j employee.A product investigation was conducted.Visual inspection: the sfx,5.5,ti, lat, size f5 (product code: 189401105 & lot no: om8923) was received at us cq.The visual inspection of the received device indicated that the device looks good except surface coating discoloration on one side.This is not consistent with the reported complaint condition; therefore, the complaint is not confirmed.Document/specification review: the relevant drawing was reviewed: dimensional inspection: the dimensional inspection was not performed as no geometrical defect found with the device.Investigation conclusion: the overall complaint was not confirmed as the device was not broken.The surface coating discoloration was observed on one side of the device.While no definitive root cause could be determined it is possible that discoloration occurred due to scratches.There is no indication that a design or manufacturing issue contributed to the complaint.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.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for sfx,5.5,ti, lat, size f5 was conducted identifying that lot number om8923 was released in 2 batches.Batch1: lot qty of (b)(4) units were released on 07mar2016 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 21apr2016 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 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
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the sfx,5.5,ti, lat, size f5 was broken.There was no patient involvement.This report is for one (1) expedium sfx cross connector system.This is report 1 of 1 for (b)(4).

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10258069
• Report Number: 1526439-2020-01315
• Device Sequence Number: 3748872
• Product Code: NKB
• UDI-Device Identifier: 10705034167718
• UDI-Public: (01)10705034167718
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: 189401105
• Device Catalogue Number: 189401105
• Device Lot Number: OM8923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1