MAUDE Adverse Event Report: IMPLANET JAZZ SYSTEMS; JAZZ CLAW HOOK

Model Number	150712
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical expertise by surgeon: a (b)(6) patient: initial intervention: correction by thoraco lumbar instrumentation with pedicle screwing.Limit of upper end in middle thoracic by 2 jazz claw hooks, no protection of upper thoracic spine.Disassembly of the 2 jazz claw took place with probable removal of the hooks placed in first intention.The assumptions made are as follows: primary cause: fracture of the last screwed vertebra and the supra vertebra causing a local kyphosis, and consequently the pull out of the jazz claw.Secondary cause: the jazz claw positioned in the middle thoracic are not used in their maximum configuration (strong mechanical constraints on a kyphosed and stiff spine) secondary cause: stopping the instrumentation in the middle thoracic involves the risk of fracture on osteoporotic spine above the most rigid instrumentation (here pedicular screw) conclusions : this type of instrumentation (jazz claw) does not seem to be the dislodging cause.It seems that the upper level of the instrumentation in middle thoracic spine with hard mechanical constraints, osteoporotic and poor bone quality are the causes.It would have been better to fix the instrumentation on the upper thoracic spine.This was performed during the second surgery.This was the best solution and could have been performed on the first intention with jazz claw with less constraints on the bones.Device discarded.
Event or Problem Description
Implantable hardware dislodged in situ due to patient pathology progression.Products removed during revision surgery 4 weeks post surgery.Alternative implantable used to replace.

• Brand Name: JAZZ SYSTEMS
• Common Device Name: JAZZ CLAW HOOK
• Manufacturer (Section D): IMPLANET; technopole bordeaux montesquie; allee francois magendie; martillac, 33650, fr
• MDR Report Key: 6633200
• Report Number: 3007675554-2017-00002
• Device Sequence Number: 10916001
• Product Code: OWI
• UDI-Device Identifier: 03607503507127
• UDI-Public: 03607503507127
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/16/2017
• Report Date (Section F): 05/19/2017

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: Physician
• Device Expiration Date: 05/28/2021
• Device Model Number: 150712
• Device Catalogue Number: 350712
• Device Lot Number: GNXF-FSTUR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2017
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/12/2017
• 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: 82 YR
• Patient Weight: 68
• Date Report Sent to FDA: 05/19/2017