MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727945
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/26/2017
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.Device not returned for evaluation.
Event or Problem Description
Revision surgery.Two loose expedium 7mm poly screw in l5 were replaced thrue a viper cfx 9x45mm screw.For both screws the 9mm viper tab was used the full length of the screw.But afterwards both screws got stuck in the pedicle when the 4-fold thread of the screws was turned into the bone.No way for screwing or unscrewing.The surgeon had to remove pedicle-bone until the 4-fold thread was free und the screws could be unscrewed.Both 9x45 cfx screws were not usable after removal.Afterwards 8mm cfx screws were used.

• Brand Name: VIPER
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7036455
• Report Number: 1526439-2017-10989
• Device Sequence Number: 1144893
• Product Code: MNI
• UDI-Device Identifier: 10705034282893
• UDI-Public: (01)10705034282893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 186727945
• Device Catalogue Number: 186727945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention