MAUDE Adverse Event Report: DEPUY SPINE INC EXP 4.5 TI SINGLE INNIE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186100001
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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
It was reported that on an unknown date, during lengthening of prior growing rod construct, the rod would not stay in the open saddle of the connector because the set screws would strip out and fail.He felt the cobalt chrome (cocr) rod needed to be contoured so it would lay in the connector saddle without resistance when placing a set screw.There was a 20-30 minutes surgical delay, procedure outcome was unknown.There was patient harm/consequence.This complaint involves six (6) devices.
Additional Manufacturer Narrative
Product complaint (b)(4).Udi (b)(4).Visual examination found that the threads on the set screw were completely torn off.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.With the information provided, a definitive root cause for the torn threads cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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, 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.

• Brand Name: EXP 4.5 TI SINGLE INNIE
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8938209
• Report Number: 1526439-2019-52050
• Device Sequence Number: 16298021
• Product Code: NKB
• UDI-Device Identifier: 10705034103846
• UDI-Public: (01)10705034103846
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 186100001
• Device Catalogue Number: 186100001
• Device Lot Number: RL278370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: Other