| Device Type ID | 4500 |
| Device Name | Template |
| Regulation Description | Template For Clinical Use. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HWT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4500 |
| Device | Template |
| Product Code | HWT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Template For Clinical Use. |
| CFR Regulation Number | 888.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 1021 |
Fracture | 214 |
Crack | 142 |
Appropriate Term/Code Not Available | 118 |
Component Missing | 75 |
Insufficient Information | 66 |
Disassembly | 34 |
Naturally Worn | 29 |
Device-Device Incompatibility | 23 |
Material Fragmentation | 23 |
Mechanical Jam | 23 |
Device Contamination With Biological Material | 22 |
Bent | 21 |
Material Deformation | 20 |
Device Operates Differently Than Expected | 17 |
Difficult To Remove | 15 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Loose Or Intermittent Connection | 15 |
Material Twisted / Bent | 14 |
Peeled / Delaminated | 12 |
Fitting Problem | 11 |
Scratched Material | 10 |
Residue After Decontamination | 10 |
Connection Problem | 10 |
Difficult To Insert | 9 |
Incorrect Measurement | 8 |
Device Dislodged Or Dislocated | 8 |
Detachment Of Device Or Device Component | 7 |
Mechanical Problem | 7 |
Separation Failure | 7 |
Detachment Of Device Component | 6 |
Device Operational Issue | 6 |
Material Integrity Problem | 5 |
Inadequacy Of Device Shape And/or Size | 5 |
Physical Resistance / Sticking | 5 |
Dull, Blunt | 5 |
Entrapment Of Device | 4 |
Malposition Of Device | 4 |
Device Markings / Labelling Problem | 4 |
Separation Problem | 4 |
Device Issue | 4 |
Unintended Movement | 3 |
Defective Device | 3 |
Device Or Device Fragments Location Unknown | 3 |
Material Distortion | 3 |
Compatibility Problem | 3 |
Unstable | 3 |
Material Discolored | 3 |
Migration Or Expulsion Of Device | 3 |
Device Reprocessing Problem | 2 |
Failure To Adhere Or Bond | 2 |
Corroded | 2 |
Defective Component | 2 |
Use Of Device Problem | 2 |
Deformation Due To Compressive Stress | 2 |
Incomplete Or Inadequate Connection | 2 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device Damaged By Another Device | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Protective Measures Problem | 1 |
Locking Mechanism | 1 |
Misassembly By Users | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Rod | 1 |
Failure To Disconnect | 1 |
Adapter (Adaptor) | 1 |
Torn Material | 1 |
Noise, Audible | 1 |
Difficult To Open Or Close | 1 |
Loss Of Or Failure To Bond | 1 |
Degraded | 1 |
Metal Shedding Debris | 1 |
Misassembled | 1 |
Misconnection | 1 |
Material Disintegration | 1 |
| Total Device Problems | 2116 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Feb-12-2018 |
| 2 | Biomet Microfixation, LLC | II | May-12-2017 |
| 3 | Biomet, Inc. | II | Jul-14-2015 |
| 4 | Biomet, Inc. | II | Oct-16-2014 |
| 5 | DePuy Orthopaedics, Inc. | II | Apr-09-2014 |
| 6 | Encore Medical, Lp | II | Jul-27-2015 |
| 7 | Integra LifeSciences Corp. | II | Apr-20-2018 |