MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP; PEDICLE SCREW

Model Number	18176550
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pedicle screw involved in this fixation failure, as well as the set screw loosened, have been examined to check if they have been degraded during the construct tightening.The dimensional analysis conducted demonstrates that both pedicle screw and set screw are in conformity with the specifications of the technical drawings.The visual examination does not indicate any abnormal surface issue or material issue.
Event or Problem Description
Two weeks post-op on a t10-l3 fusion construct for vertebral fracture treatment, the pedicle screw on contra-lateral side was pulled out of pedicle.As a consequence, the set screw loosened.The patient needed a revision surgery to resecure the construct.The construct was lengthened to l4 and pedicle screws which pulled out were replaced.The revision surgery was completed without further complications.

• Brand Name: ERISMA-LP
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 8149918
• Report Number: 3009962553-2018-00002
• Device Sequence Number: 1658086
• Product Code: NKB
• UDI-Device Identifier: 03700780618323
• UDI-Public: (01)03700780618323(10)I265X(11)180301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 18176550
• Device Catalogue Number: 18176550
• Device Lot Number: I265X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: 60 YR