MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186715000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Spinal Column Injury (2081)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).One mis single inner setscrew was returned to the complaints handling unit (chu) for evaluation.Visual examination of the mis single-inner setscrew revealed signs of operative use as evidenced by superficial markings, with threads and drive feature slightly worn.It was noted that the rod striations were observed on the set screw suggesting that the set screw was seated properly.Unusual witness marks were noted on the surface of the screw as opposing to the general rod striations suggesting that the set screw might have loosened.A device history record review identified no issues that could have cause or contributed to the reported event.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 loosening of the single-inner setscrew cannot be determined.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.As such the 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 Description

Sales rep informed us concerning postoperative loosening of an unknown number of exp innies.Doi: unknown, dor: unknown.

• Brand Name: MIS SINGLE INNER SETSCW
• 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: 7763873
• MDR Text Key: 116457043
• Report Number: 1526439-2018-50763
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: (01)10705034121192
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715000
• Device Catalogue Number: 186715000
• Device Lot Number: 174176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• 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 Outcome(s): Required Intervention