MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 498.104

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 on (b)(6) 2020, the patient had an l3-s1 (no screw at left l4) posterior spinal fusion with synthes uss on (b)(6) 2018.At an unknown point in time the patient broke the left rod just cranial to the s1 screw.The surgeon said that the patient has a non union at l5-s1.During the revision surgery on (b)(6) 2020, surgeon removed both rods.He also replaced both s1 screws, and the left l5 screw.These 3 screws were loose, and he replaced them with larger diameter uss screws.He then placed new rods, connected them and successfully completed the procedure.The rods removed from the 2018 procedure were 6.0mm titanium hard rod, and both rods were removed.Only the left rod was broken.There is no allegation with the right rod.The reason why the surgeon also removed the right rod was surgeon wanted to replaced the right rod because he was already exposed to replace the left rod.It can be assumed that the right rod would be ¿weakened¿ although not broken.He wanted two (2) new rods to give the patient the best possible chance to heal.The lot numbers of both were not legible to rea, and they are unknown.Also it is unknown the sizes and lot numbers of the 3 screws that were removed and replaced.The patient or customer is retaining the hardware.There is no patient consequence.This report is for one (1) 6.0mm ti hard rod 100mm.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Updated event description: it was reported that on (b)(6) 2020, the patient underwent revision surgery due to broken left rod and loosened 3 screws in both s1 and left l5.The patient had a l3-s1 (no screw at left l4) posterior spinal fusion with synthes uss on (b)(6) 2018.At an unknown point in time the patient broke the left rod just cranial to the s1 screw.The surgeon said that the patient has a non union at l5-s1.During the revision surgery, the surgeon removed both rods.Both s1 screws, and the left l5 screws were replaced with larger diameter uss screws.The surgeon placed new rods, connected them and successfully completed the procedure.The rods removed from the 2018 procedure were 6.0mm titanium hard rods.There is no allegation with the right rod.The reason why the surgeon also removed the right rod was surgeon wanted to replaced the right rod because he was already exposed to replace the left rod.It can be assumed that the right rod would be ¿weakened¿ although not broken.He wanted two (2) new rods to give the patient the best possible chance to heal.It was unknown the sizes/lots of the 3 screws that were removed and replaced.There was no patient consequence.This complaint involves four (4) devices.

• Brand Name: 6.0MM TI HARD ROD 100MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10771000
• MDR Text Key: 214135204
• Report Number: 2939274-2020-04920
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034788852
• UDI-Public: (01)10705034788852
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 498.104
• Device Catalogue Number: 498.104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS; UNK - SCREWS; UNK - SCREWS; UNK - SCREWS; UNK - SCREWS; UNK - SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR