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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Spinal Column Injury (2081)

Event Date 08/27/2018

Event Type  Injury  

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 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
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7894549
• MDR Text Key: 120894737
• Report Number: 1526439-2018-50902
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034171579
• UDI-Public: (01)10705034171579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189602000
• Device Catalogue Number: 189602000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR