MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 SS SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189602000
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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 that dr.(b)(6) was doing a revision on the patient on monday (b)(6) 2018, he implanted another rod with open 6.35 connectors.This implantation procedure was unilateral.Upon exploration, he saw the set screw was extremely loose.Once he gained better exposure, he saw the threaded area of the lateral connector splayed.After removing the lateral connector, he saw the base cracked.Dr.(b)(6) replaced the connector with a new one.(1896-92-050).

• Brand Name: EXP 635 SS SI SETSCREW
• 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: 7894549
• Report Number: 1526439-2018-50902
• Device Sequence Number: 13930275
• Product Code: NKB
• UDI-Device Identifier: 10705034171579
• UDI-Public: (01)10705034171579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189602000
• Device Catalogue Number: 189602000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 31 YR