MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179771555

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fever (1858); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

The reported device was implanted on unknown date.It was reported that the rod was come off from the reported connector (p/n: 179771555).The sales force scheduled an interview the surgeon and will collect more detail.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #
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> (b)(4).Udi: ((b)(4).Visual examination of the universal connector revealed signs of operative use as evidenced by superficial markings, with threads and drive feature slightly worn.Rod striations were observed on the set screws suggesting that the set screw was seated and tightened properly.It was also noted that debris is visible inside the notch, which is suspected to be soft tissue or bone in growth.A review of the device history record could not be performed as the lot number was obscured by the tool marks.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 of the migration and loosening of the universal connector 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.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.

Manufacturer Narrative

(b)(4).

• Brand Name: CONN O/O SD TOP NTCH 5.5X5.5 T
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8219212
• MDR Text Key: 132202935
• Report Number: 1526439-2019-51196
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW207284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention