MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH DI POLYAXL SCREW 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
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
Rev t3-pelvis, broken rods at l5/s1; (b)(6), (b)(6) hospital (b)(6) 2018.Pt in for surgery for broken rods at l5/s1 on both sides.Existing construct - t3-pelvis ((b)(6) 2015).Surgeon stated that there was no obvious non union.Replaced screws and rods, at l4-pelvis.Also noted that when he went to remove the iliac screw on the l) side, the screw head broke off from the shaft.The surgeon left this in the patient and placed another screw in the pelvis.The rods were removed and replaced and joined to the remaining construct with axial connectors.

• Brand Name: DI POLYAXL SCREW 8 X 80MM
• 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: 7568675
• Report Number: 1526439-2018-50522
• Device Sequence Number: 2629448
• Product Code: NKB
• UDI-Device Identifier: 10705034071046
• UDI-Public: (01)10705034071046
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

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: 179722880
• Device Catalogue Number: 179722880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR