MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH IEXP DDV TI SLOTTED CONN STRT; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	175450010
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Depression (2361); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
During the post op control the surgeon and the patient have seen on xrays that one of the lower offset connector has moved and was no more in the original position.The patient also wrote a complaint letter on it.This letter and the x-ray can be found enclosed.Procedure: lumbar fixation + plif.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device did not show any signs of damage.Light tool markings showed that it had seen some use.The returned image showed that the bolt and its associated parts had shifted postoperatively, moving away from the rod that it was supposed to be attached to.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.The root cause of the connector shifting postoperatively cannot be determined from the sample and the information provided.A potential root cause may be the associated set screw loosening from the top of the rod postoperatively, potentially allowing the connector to migrate.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.
Additional Manufacturer Narrative
Device received.Investigation will be conducted.

• Brand Name: IEXP DDV TI SLOTTED CONN STRT
• 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: 7442847
• Report Number: 1526439-2018-50382
• Device Sequence Number: 16425308
• Product Code: NKB
• UDI-Device Identifier: 10705034251684
• UDI-Public: (01)10705034251684
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• 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,Followup
• Report Date (Section B): 03/23/2018

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: 175450010
• Device Catalogue Number: 175450010
• Device Lot Number: BDKW8SM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 05/01/2018; 05/31/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/18/2018; 05/18/2018; 05/31/2018
• 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
• Patient Age: 45 YR