MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCW 5MMX40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179788540
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: complaint summary: it was reported on an unknown date, the expedium 5.5 uniplanar screw failed to accept set screw when trying to implant rod.It appears the screw head may have splayed and the tulip threads are damaged.Procedure outcome is unknown.There was no patient consequence.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition for damaged threads could be confirmed as the image provided shows damaged threads.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for exp ti uni scw 5mmx40mm was conducted identifying that lot number rl264069 was released in a single batch.Batch1: lot was released on nov 28, 2017 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 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.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, the expedium 5.5 uniplanar screw failed to accept set screw when trying to implant rod.It appears the screw head may have splayed and the tulip threads are damaged.Procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown insertion instruments (part# unknown, lot# unknown, quantity unknown).This report is for one (1) exp ti uni scw 5mmx40mm.This is report 1 of 2 for (b)(4).

• Brand Name: EXP TI UNI SCW 5MMX40MM
• 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: 10510010
• Report Number: 1526439-2020-01629
• Device Sequence Number: 3134217
• Product Code: NKB
• UDI-Device Identifier: 10705034081229
• UDI-Public: (01)10705034081229
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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: 179788540
• Device Catalogue Number: 179788540
• Device Lot Number: RL264069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• Patient Sequence Number: 1