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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APIFIX LTD MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

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APIFIX LTD MID-C 95; POSTERIOR RATCHETING ROD SYSTEM Back to Search Results
Model Number MID-C 95
Device Problems Unintended Movement (3026); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Discomfort (2330)
Event Date 10/07/2021
Event Type  Injury  
Manufacturer Narrative
First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.
 
Event Description
The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.
 
Manufacturer Narrative
First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.
 
Event Description
The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.
 
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Brand Name
MID-C 95
Type of Device
POSTERIOR RATCHETING ROD SYSTEM
Manufacturer (Section D)
APIFIX LTD
1 hacarmel street
kochav yokneam bldg
yokneam elit, 20692 07
IS  2069207
Manufacturer (Section G)
APIFIX LTD
1 hacarmel street
kochav yokneam bldg
yokneam elit, 20692 07
IS   2069207
Manufacturer Contact
adi prager
1 hacarmel street
kochav yokneam bldg
yokneam elit, 20692-07
IS   2069207
MDR Report Key12849772
MDR Text Key285486753
Report Number3013461531-2021-00039
Device Sequence Number1
Product Code QGP
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
H170001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2021
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 Expiration Date05/17/2021
Device Model NumberMID-C 95
Device Catalogue NumberAF95
Initial Date Manufacturer Received 10/13/2021
Initial Date FDA Received11/20/2021
Date Device Manufactured05/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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