MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Pt scheduled for revision l5-s1 fusion.Pt presented with bilateral s1 broken screws (7.0 x 35mm expedium polys).Existing hardware at s1 was removed using trephines and screw extractors.S1 screws were replaced with 8.0 x 35mm polys.The left s1 screw was inserted until the distal tip reached the contralateral cortex of the sacrum.Surgeon felt screw was too proud and attempted to advance the screw shearing of the tip of the expedium quick connect poly driver into the shank of the screw.Surgeon tried to advance by locking rod into screw and turning with countertorque with no results.Surgeon removed screw head with diamond bur and attempted to remove shank with screw extractor, no results.Surgeons abandoned the screw removal and completed the construct from l4-ileum.No further issues.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: SI POLYAXL SCREW 7 X 35MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7558200
• Report Number: 1526439-2018-50517
• Device Sequence Number: 1871933
• Product Code: NKB
• UDI-Device Identifier: 10705034067889
• UDI-Public: (01)10705034067889
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179712735
• Device Catalogue Number: 179712735
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 111