MAUDE Adverse Event Report: ZIMMER TMT UNKNOWN TM-S CAGE; METALLIC SPINAL INTERBODY FUSION CAGE

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Unable to perform a field action check.Item number and lot number were not provided.Medical records were not provided.A definitive root cause cannot be determined.

Event Description

It was reported that patient underwent a spine procedure on an unknown date.Subsequently, patient underwent a revision procedure due to disassociation of the cage/subsidence of the cage.During the revision surgery the cage was removed.There are other cases.No other information available.

• Brand Name: UNKNOWN TM-S CAGE
• Type of Device: METALLIC SPINAL INTERBODY FUSION CAGE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 11752410
• MDR Text Key: 248400840
• Report Number: 3005751028-2021-00041
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TM-S CAGE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention