MAUDE Adverse Event Report: CAMBER SPINE TECHNOLOGIES ENZA ZERO-PROFILE ANTERIOR INTERBODY FUSION; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number CB-001-031

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The surgeon reported that the patient had undergone a level 3 alif (l3-s1) surgery on (b)(6) 2018 with no complications.The patient had a 2nd surgery on (b)(6) 2018 to place pedicle screws at l4-l5 as planned.Both surgeries were performed as intended with no reported complications.It was reported by a camber sales rep that during a routine 6-week post-op appointment on (b)(6) 2018, patient x-rays of the operative levels indicated that the implant at l3-l4 had migrated from the original implant site.Revision surgery was performed on (b)(6) 2018.During this procedure, the surgeon confirmed the migration of the l3-l4 implant and extracted the device.This device was replaced with another implant.In addition, the surgeon verified the placement of the original l4-l5 and l5-s1 implants from the original level 2 alif and reported that implants were located in the correct positions (i.E., no other migration).The surgeon reported that the surgery was performed as intended with no complication.As a follow-up, the surgeon provided a statement documenting that he inspected the implant and believes that there are no structural defects.

Event Description

It was reported by a camber sales rep that during a routine 6-week post-op appointment on (b)(6) 2018, a patient's x-rays indicated that the camber enza implant ((b)(6); l/n jp02017k) had migrated from the original position in the l3-l4 disc space.Revision surgery was performed on (b)(6) 2018, and the surgeon extracted the device.This implant was replaced with another device.

• Brand Name: ENZA ZERO-PROFILE ANTERIOR INTERBODY FUSION
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): CAMBER SPINE TECHNOLOGIES; 418 east lancaster ave.; wayne 19087
• Manufacturer (Section G): CAMBER SPINE TECHNOLOGIES; 418 east lancaster ave; wayne 19087
• Manufacturer Contact: erin kriebel ; 418 east lancaster ave; wayne 19087 ; 4844277060
• MDR Report Key: 7472669
• MDR Text Key: 107405149
• Report Number: 3010197239-2018-00007
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CB-001-031
• Device Lot Number: JP02017K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention