MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721650
Medical Device Problem Codes	Material Deformation (2976); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).The 5.5 exp verse screw 6.0 x 50 was not returned to the complaints handling unit (chu) for evaluation.Three requests were made to have the device sample returned for evaluation.A device history record review could not be conducted as the lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause cannot be determined with the information provided.No issues could be identified in the manufacturing or release of this product since the lot number could not be identified.Therefore, this complaint 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
(b)(6); big heads leigh after spondy reduction.Locking cap came out by using the torque.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device revealed that the threads inside the tulip head were completely peeled off with minor damage to the drive feature.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the 5.5 exp verse scr 6.0x50 cannot be determined.This damage may have occurred due to cross-threading a set screw upon insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, 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.

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 50
• 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: 7466143
• Report Number: 1526439-2018-50417
• Device Sequence Number: 160173
• Product Code: NKB
• UDI-Device Identifier: 10705034442266
• UDI-Public: (01)10705034442266
• Combination Product (Y/N): N
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2018

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: 199721650
• Device Catalogue Number: 199721650
• Device Lot Number: AVKBGP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 05/16/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 04/30/2018; 05/24/2018
• 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