MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 5X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731550
Medical Device Problem Codes	Disconnection (1171); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).One viper 5.5 ti 5x50mm cortical fix polyaxial screw was received by the customer quality unit for evaluation.Visual examination found that the polyaxial¿s tulip head inner cap had disassembled from its intended location.No damage was present on the polyaxial screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.As a result, it is suggested that unanticipated high amount of "forces" was placed on the tulip head resulting in the inner cap becoming disassembled from its intended location.It was noted that the threads on the polyaxial¿s tulip head had become torn.Noted damage suggests that its matting device was likely not properly seated and inadvertently cross threading occurred, resulting in the threads becoming torn.A device history record review did not identify any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the inner cap becoming rotated from its intended position and the tulip head threads becoming torn cannot be positively determined.However, noted damage suggests that unanticipated high amount of "forces" was placed on the tulip head resulting in the inner cap becoming disassembled from its intended location.Also, it is suggested that inadvertently cross threading occurred, resulting in the threads becoming torn.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, this complaint file will be closed with no further action required.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
It was reported the viper cortical fix screw 1867-31-550¿s tulip head disengaged from the shank.Patient consequence? no.Action taken for procedure: screw was successfully removed.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: 5.5 TI CORT FIX 5X50MM
• 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: 8029731
• Report Number: 1526439-2018-51035
• Device Sequence Number: 1131495
• Product Code: NKB
• UDI-Device Identifier: 10705034351643
• UDI-Public: (01)10705034351643
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731550
• Device Catalogue Number: 186731550
• Device Lot Number: ARLCZN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR