MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: kwp; kwq; mnh; mni; osh.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on january 4, 2021 that the patient reported an allergy after being implanted with the expedium implants on an unknown date.No further information was provided.This report is for one (1) si polyaxl screw 6 x 40mm.This is report 5 of 5 for (b)(4).

• Brand Name: SI POLYAXL SCREW 6 X 40MM
• 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: 11233957
• Report Number: 1526439-2021-00202
• Device Sequence Number: 19903387
• Product Code: NKB
• UDI-Device Identifier: 10705034067728
• UDI-Public: 10705034067728
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 179712640
• Device Catalogue Number: 179712640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 480 MM; SI POLYAXL SCREW 5 X 40MM; SI POLYAXL SCREW 5 X 45MM; SINGLE-INNER SETSCREW