MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown vertebral spacer cage.Part#, lot# and udi # is not available.Device remained implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown vertebral spacer cage.Pma/510(k) number is not available.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 the patient was initially implanted with a synthes vertebral spacer-tr cage and a depuy spine expedium construct from t10-iliac on an unknown date.The surgeon discovered that the cage backed out of the l5-s1 disc space and the s1 (sacrum) was fractured when films were ordered after a visit with the patient.The patient had scheduled a follow-up with the surgeon because she was experiencing pain and weakness after she twisted and heard a ¿snap¿ in her back.This is what caused the revision surgery.The patient underwent a revision surgery on (b)(6) 2018 due to a backed-out cage and a fractured sacrum.Surgeon tamped the cage back into place and it is still in the patient.No surgical delay was reported.Procedure was completed successfully.Patient was reported to be recovering.This complaint is linked with (b)(4) which captures the depuy spine devices.Concomitant devices reported: expedium titanium poly screw 8mmx45mm (part # 179712845, lot # unknown, quantity # 1), expedium screw (part # unknown, lot # unknown, quantity # 3), expedium rods (part # unknown, lot # unknown, quantity # 2), expedium locking caps (part #, lot #, quantity # unknown), expedium cross-links (part # unknown, lot # unknown, quantity # 2).This report is for one (1) unknown vertebral spacer cage.This is report 1 of 1 for (b)(4).

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7392340
• MDR Text Key: 104194212
• Report Number: 2939274-2018-51408
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• 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
• Patient Age: 57 YR
• Patient Weight: 90