MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712745
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).Lot unknown.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.Device not returned.
Event or Problem Description
Implant broke during insertion.Complaint form sent to rep per complaint form: when placing the revision screw, the screwdriver made a popping noise which was the tip of the driver breaking.The tip was stuck in the screw and we had to attach a rod to remove.We broke off the head of the screw attempting to remove and then used a reverse threaded removal tip in order to remove the screw shaft.

• Brand Name: SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6824422
• Report Number: 1526439-2017-10716
• Device Sequence Number: 482440
• Product Code: NKB
• UDI-Device Identifier: 10705034067902
• UDI-Public: (01)10705034067902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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?: Yes
• Operator of Device: Physician
• Device Model Number: 179712745
• Device Catalogue Number: 179712745
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR