MAUDE Adverse Event Report: CERAPEDICS INC I-FACTOR PUTTY; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number 700-050

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The dhr was reviewed for lot 21c1149 and indicated no abnormal processing.The lot in question met all specifications prior to its release.There have been no ncrs or capas associated with this lot.Cerapedics risk analysis document ra-001, revision 23 (putty) was reviewed.The failure mode identified in this complaint is already identified under line item 38 (potential effect 2) - "inadequate retention in graft site, migration." therefore, no updates to the risk assessment are required.There have been 8 (eight) previous complaints related to this potential failure mode.Based on the total number of units distributed (n=265,783), the observed rate is 0.003%.The mitigated risk probability for this potential failure mode is estimated to be 1 or an estimated occurrence rate of 0.01%.Therefore, the benefit-risk analysis remains unchanged.Us putty ifu (p/n 40002-07-4) lists the following as a potential adverse effect: "extrusion or migration of the i-factor peptide enhanced bone graft, as is possible with any bone graft, resulting in pain, neural impingement, physical impairment, or loss of function; any of which may require revision surgery." as such, no updates are required for the ifu.

Event Description

Tlif cage subsided and graft material migrated into the spinal canal.Patient developed cauda equina syndrome.Patient required decompression surgery.

• Brand Name: I-FACTOR PUTTY
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS INC; 11025 dover street; suite #1600; westminster CO 80021
• Manufacturer (Section G): CERAPEDICS INC; 11025 dover street; suite #1600; westminster CO 80021
• Manufacturer Contact: emily aulby ; 11025 dover street; suite #1600; westminster, CO 80021
• MDR Report Key: 18886185
• MDR Text Key: 337443691
• Report Number: 3007155473-2024-22120
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 0085001680028
• UDI-Public: (01)0085001680028(17)241130(10)21C1149
• Combination Product (y/n): Y
• PMA/PMN Number: P140019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 700-050
• Device Lot Number: 21C1149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GRAFTON DBF, AUTOGRAPH AND TLIF CAGE; PATIENT REQUIRED DECOMPRESSION SURGERY.
• Patient Outcome(s): Other
• Patient Age: 46 YR